Trial Outcomes & Findings for Noninvasive Brain Stimulation for Mild Cognitive Impairment (NCT NCT03331796)
NCT ID: NCT03331796
Last Updated: 2025-09-03
Results Overview
The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. The total number of words correctly recalled on the 5 list-learning trials was computed (range = 0 to 80). Higher values represent a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.
Results posted on
2025-09-03
Participant Flow
Participants were enrolled at the Stanford/VA Aging Clinical Research Center over a 4-year period, which included a 13-month hiatus during the Coronavirus disease (COVID-19) pandemic. The study was open for recruitment on 05/16/2018. The first participant was enrolled and randomized on 06/15/2018; the last participant was enrolled and randomized on 11/22/2022.
Of 69 consented, screened participants, 40 participants met inclusion/exclusion criteria and were randomized to treatment. This was a dyad study, such that each amnestic Mild Cognitive Impairment (aMCI) participant who enrolled in the study had a study partner whose role was to provide collateral data about the primary participant's everyday functioning. Study partners were not assessed for outcomes such as caregiver burden; therefore, the study partners are not considered enrolled.
Participant milestones
| Measure |
Active rTMS (Bilateral DLPFC)
One-third of participants will receive active repetitive transcranial magnetic stimulation (rTMS) to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Placebo rTMS (Inactive)
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Allocation and Primary Endpoint
STARTED
|
14
|
13
|
13
|
|
Allocation and Primary Endpoint
COMPLETED
|
14
|
12
|
11
|
|
Allocation and Primary Endpoint
NOT COMPLETED
|
0
|
1
|
2
|
|
Extended Follow-up
STARTED
|
14
|
12
|
11
|
|
Extended Follow-up
COMPLETED
|
12
|
11
|
9
|
|
Extended Follow-up
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Active rTMS (Bilateral DLPFC)
One-third of participants will receive active repetitive transcranial magnetic stimulation (rTMS) to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Placebo rTMS (Inactive)
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Allocation and Primary Endpoint
Pandemic Disruption
|
0
|
1
|
1
|
|
Allocation and Primary Endpoint
Withdrawal by Subject
|
0
|
0
|
1
|
|
Extended Follow-up
Adverse Event
|
1
|
0
|
1
|
|
Extended Follow-up
Lost to Follow-up
|
0
|
0
|
1
|
|
Extended Follow-up
Withdrawal by Subject
|
1
|
0
|
0
|
|
Extended Follow-up
Termination of Funding
|
0
|
1
|
0
|
Baseline Characteristics
Two participants did not complete the measure due to lack of time (1, Active DLPFC) and pandemic disruption (1, Sham).
Baseline characteristics by cohort
| Measure |
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 5.8 • n=14 Participants
|
75.7 years
STANDARD_DEVIATION 7.5 • n=12 Participants
|
74.0 years
STANDARD_DEVIATION 5.3 • n=11 Participants
|
74.4 years
STANDARD_DEVIATION 6.1 • n=37 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
6 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
16 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
6 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
21 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants
|
10 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
33 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=14 Participants
|
8 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
27 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=37 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
37 participants
n=37 Participants
|
|
Education
|
17.0 years
STANDARD_DEVIATION 2.7 • n=14 Participants
|
16.9 years
STANDARD_DEVIATION 2.2 • n=12 Participants
|
17.1 years
STANDARD_DEVIATION 2.5 • n=11 Participants
|
17.0 years
STANDARD_DEVIATION 2.4 • n=37 Participants
|
|
Mild Cognitive Impairment Stage
Early
|
6 Participants
n=14 Participants
|
7 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
18 Participants
n=37 Participants
|
|
Mild Cognitive Impairment Stage
Late
|
8 Participants
n=14 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
19 Participants
n=37 Participants
|
|
Clinical Dementia Rating Scale Sum of Boxes Score
|
1.3 units on a scale
STANDARD_DEVIATION 0.7 • n=14 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.5 • n=12 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 0.6 • n=11 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 0.6 • n=37 Participants
|
|
Logical Memory II subscale (Delayed Recall, Story A only)
|
6.3 units on a scale
STANDARD_DEVIATION 2.1 • n=14 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 3.4 • n=12 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 2.6 • n=11 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 2.9 • n=37 Participants
|
|
Baseline Global Cognitive Function, as Measured by the Montreal Cognitive Assessment total score
|
23.6 units on a scale
STANDARD_DEVIATION 4.6 • n=13 Participants • Two participants did not complete the measure due to lack of time (1, Active DLPFC) and pandemic disruption (1, Sham).
|
23.9 units on a scale
STANDARD_DEVIATION 3.6 • n=12 Participants • Two participants did not complete the measure due to lack of time (1, Active DLPFC) and pandemic disruption (1, Sham).
|
23.9 units on a scale
STANDARD_DEVIATION 2.7 • n=10 Participants • Two participants did not complete the measure due to lack of time (1, Active DLPFC) and pandemic disruption (1, Sham).
|
23.8 units on a scale
STANDARD_DEVIATION 3.7 • n=35 Participants • Two participants did not complete the measure due to lack of time (1, Active DLPFC) and pandemic disruption (1, Sham).
|
|
Baseline Depressive Symptoms, as Measured by the Geriatric Depression Scale Total Score
|
2.6 units on a scale
STANDARD_DEVIATION 1.6 • n=14 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 1.3 • n=12 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.3 • n=11 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.5 • n=37 Participants
|
|
Total number of words correctly recalled, List Learning, California Verbal Learning Test-II
|
36.1 total number of words correctly recalled
STANDARD_DEVIATION 10.5 • n=14 Participants
|
47.0 total number of words correctly recalled
STANDARD_DEVIATION 10.2 • n=12 Participants
|
39.7 total number of words correctly recalled
STANDARD_DEVIATION 11.2 • n=11 Participants
|
40.7 total number of words correctly recalled
STANDARD_DEVIATION 11.3 • n=37 Participants
|
PRIMARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided primary outcome data at the 1-week primary endpoint.
The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. The total number of words correctly recalled on the 5 list-learning trials was computed (range = 0 to 80). Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Total Number of Words Correctly Recalled, List Learning, California Verbal Learning Test-II, Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
37.0 total number of words correctly recalled
Standard Deviation 11.4
|
36.1 total number of words correctly recalled
Standard Deviation 11.0
|
48.8 total number of words correctly recalled
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 3 months after completing the 20-session intervention (acceptable window for assessment: 76-104 days after the final intervention session)Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 3-month follow-up endpoint.
The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. The total number of words correctly recalled on the 5 list-learning trials was computed (range = 0 to 80). Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=9 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Total Number of Words Correctly Recalled, List Learning, California Verbal Learning Test-II, Assessed 3 Months After Intervention and Adjusted for Baseline Performance
|
41.3 total number of words correctly recalled
Standard Deviation 6.9
|
38.4 total number of words correctly recalled
Standard Deviation 10.3
|
53.0 total number of words correctly recalled
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of 16 semantically related words and remember the list after a delay interval. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. A measure of semantic clustering is calculated by a computer program. It is a measure of the participant's tendency to recall words in semantically organized clusters (e.g. the participant recalled "apple" and "orange" even though the two fruit words were not presented sequentially). The computer algorithm includes words recalled on Trials 1-5 and adjusts for the possibility that a semantic cluster occurred by chance. The range of CVLT-II Semantic Clustering Scores is -3 to 9. Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
California Verbal Learning Test-II (CVLT-II) Semantic Clustering Score, 1 Week After Intervention and Adjusted for Baseline Performance
|
0.1 score on a scale
Standard Deviation 0.6
|
0.5 score on a scale
Standard Deviation 1.0
|
0.5 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the interventionPopulation: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. After 5 learning trials and a subsequent 20-minute delay filled with unrelated tests, the participant was asked to recall the 16-word target list of the CVLT-II again. The total number of words correctly recalled was computed (range = 0 to 16). Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Total Number of Words Correctly Recalled During the "Long Delay Free Recall" Component of the California Verbal Learning Test-II (CVLT-II), Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
6.2 total number of words correctly recalled
Standard Deviation 3.5
|
6.2 total number of words correctly recalled
Standard Deviation 4.2
|
10.3 total number of words correctly recalled
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The 15-item Geriatric Depression Scale (GDS) was also used as an outcome measure. Five of the GDS items are oriented toward the absence of depressive symptoms (e.g., Do you feel full of energy?) and 10 are oriented toward current depressive symptoms (e.g., Do you often feel helpless?). The participant is asked to answer "yes" or "no" on the basis of how they have been feeling over the past week. The GDS total score ranges from 0 to 15. Lower values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Depressive Symptoms, as Measured by the Geriatric Depression Scale (GDS), Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
2.9 score on a scale
Standard Deviation 2.3
|
3.2 score on a scale
Standard Deviation 2.3
|
1.9 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the interventionPopulation: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The Everyday Cognition (ECog) questionnaire is comprised of 39 items about the ability to perform everyday tasks. Each item relates to memory, language, visual-spatial, or executive function. Each item is rated on a scale from 1 to 4 (1 = better or no change…4 = consistently much worse compared to 10 years ago). For the Participant version of the ECog, the participant is asked to "Please rate your ability to perform certain everyday tasks now, as compared to your ability to do these same tasks 10 years ago." Total score range: 39-156. Higher values represent a worse outcome. The outcome score was adjusted for baseline.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Everyday Functional Outcomes, as Measured by the Everyday Cognition (ECog) Questionnaire (Participant Version) Completed 1 Week After Intervention
|
72.3 score on a scale
Standard Deviation 16.1
|
84.8 score on a scale
Standard Deviation 21.0
|
66.1 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the interventionPopulation: The population analyzed included the study partners of all participants who received at least 1 session of the intervention and whose study partner provided outcome data at the 1-week endpoint.
The Everyday Cognition (ECog) questionnaire is comprised of 39 items about the ability to perform everyday tasks. Each item relates to memory, language, visual-spatial, or executive function. Each item is rated on a scale from 1 to 4 (1 = better or no change…4 = consistently much worse compared to 10 years ago). For the Informant version of the ECog, the participant's study partner was asked to "Please rate the participant's ability to perform certain everyday tasks NOW, as compared to his/her ability to do these same tasks 10 years ago." Total score range: 39-156. Higher values represent a worse outcome. The outcome score was adjusted for baseline.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=5 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=9 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Everyday Functional Outcomes, as Measured by the Everyday Cognition Questionnaire (Informant /Study Partner Version) Completed 1 Week After Intervention
|
61.5 score on a scale
Standard Deviation 29.2
|
73.2 score on a scale
Standard Deviation 30.9
|
61.1 score on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included the study partners of all participants who received at least 1 session of the intervention and whose study partners provided outcome data at the 1-week endpoint.
Functional Assessment Questionnaire, completed by the study partner at end of treatment (1 week after intervention, adjusted for baseline). Each 10 item is rated on a scale from 0 to 3 (0 = Normal; 1 = Has difficulty, but does by self; 2 = Requires assistance; 3 = Dependent. Total score range: 0-30 (sum of 10 items). Interpretation: A total score of 9 (dependent in 3 or more activities) is the recommended cut-point for an indication of impaired function. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=6 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=9 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Instrumental Activities of Daily Living (IADLs), as Measured by the Functional Assessment Questionnaire, Completed 1 Week After Intervention
|
1.33 score on a scale
Standard Deviation 3.27
|
3.29 score on a scale
Standard Deviation 4.41
|
1.00 score on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the interventionPopulation: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The Montreal Cognitive Assessment (MoCA) is a brief measure of global cognitive function. The total score has a range of 0 to 30; higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=10 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Global Cognitive Function, as Measured by the Montreal Cognitive Assessment (MoCA), Assessed 1 Week After Intervention and Adjusted for Baseline
|
23.6 score on a scale
Standard Deviation 2.2
|
23.0 score on a scale
Standard Deviation 4.5
|
23.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
Brief Visuospatial Memory Test-Revised (BVMT-R) Trials 1-3 total recall raw score at end of treatment (1 week after intervention, adjusted for baseline); range: 0-36; higher values represent a better outcome
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=10 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Visuospatial Memory, as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), assessed1 Week After Intervention and Adjusted for Baseline Performance
|
21.6 score on a scale
Standard Deviation 6.5
|
17.8 score on a scale
Standard Deviation 8.5
|
18.5 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
Category Fluency is a measure of verbal fluency in which the participant is asked to generate different exemplars from a semantic category specified by the examiner. For example, if the examiner says, 'articles of clothing,' correct responses include exemplars such as, 'shirt,' 'tie,' or 'hat.' The participant is given one minute to say all the responses they can think of. The values reported reflect the total number of correct, unique responses produced. Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=11 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=14 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Language Function, as Measured by Category Fluency (CF), Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
19.4 correct, unique responses
Standard Deviation 6.0
|
16.7 correct, unique responses
Standard Deviation 3.8
|
19.8 correct, unique responses
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
The Boston Naming Test (BNT) assesses the ability to verbally name pictured objects. The subject is shown a series of line drawings and asked to name the object. The test items become progressively more difficult. (The 42 items are presented in order of decreasing frequency of the target word). The total number of correct responses can range from 0 to 42. Higher values represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=10 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Language Function, as Measured by 42-item Boston Naming Test (BNT), Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
35.9 correct responses
Standard Deviation 4.8
|
36.3 correct responses
Standard Deviation 3.9
|
38.4 correct responses
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
Rey-Osterrieth Complex Figure (ROCF) Copy score at end of treatment (1 week after intervention, adjusted for baseline); range: 0-36; higher values represent a better outcome
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=10 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Visuoconstructional Function, as Measured by the Rey-Osterrieth Complex Figure (ROCF) Copy Score, assessed1 Week After Intervention and Adjusted for Baseline Performance.
|
34.9 score on a scale
Standard Deviation 1.8
|
33.8 score on a scale
Standard Deviation 4.1
|
32.7 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: The population analyzed included all participants who received at least 1 session of the intervention and who provided outcome data at the 1-week endpoint.
In the Trail Making Part B test, the response form has a series of 25 circles; each circle contains a number or a letter. The participant is asked to connect the circles in order by alternating between the numbers and letters. The maximum time allowed is 300 seconds. Trails B is thought to require executive skills as well as processing speed. The Trail Making B seconds-to-complete scores were log transformed because the distribution of scores was positively skewed. We also reverse scored the log scores so that higher values would indicate a better outcome. To reverse the log scores, we used the formula: reverse score = max(x) + 1 - x, where max(x) is the natural log of 300 or 5.70378. For example, if a participant's time-to-complete score was 74 seconds, the natural log transformed score was 4.304. Reverse scoring yields a value of 2.4 (2.4 = 5.70378 + 1 - 4.304). The reverse-scaled, log transformed seconds-to-complete scores were used in all statistical analyses.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=10 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=11 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Speed of Processing and Executive Function, as Measured by Trail Making Part B, Assessed 1 Week After Intervention and Adjusted for Baseline Performance
|
2.42 reverse scaled, log transformed scores
Standard Deviation 0.33
|
2.11 reverse scaled, log transformed scores
Standard Deviation 0.64
|
2.42 reverse scaled, log transformed scores
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: planned: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: There are no data to report in the Outcome Measure Data Table because the protocol was modified (i.e., amended) to not administer the Attention Network Task. The amendment can be found on page 63 of the updated Study Protocol and Statistical Analysis Plan, dated 09/19/2019.
Attentional Network Task(ANT) correct reaction time, as measured by the ANT computerized test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: planned: 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.Population: Data cannot be reported because change from Baseline in Functional connectivity metrics required post-intervention resting-state functional magnetic resonance imaging (fMRI) scan data that could not be acquired after March of 2020 due to COVID-19 suspension of in-person research and subsequent early termination of the NIA award in August of 2021.
Change from Baseline in Functional connectivity metrics (derived from the pre- and the post-intervention functional magnetic resonance imaging (fMRI) scans rs-fMRI scans) will be computed with respect to: connectivity within the Default Mode Network (DMN), and connectivity between the DMN and the Central Executive Network (CEN).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First Intervention session to Last Intervention session. The average time frame from the first to the 20th and last session is 18 days.Population: All participants who had BDNF plasma results for both pre- and post-intervention, i.e. during the first session and the last session of TMS. Additional comments: (1) All of these participants were treatment adherent per study protocol, i.e., they completed at least 18 of the 20 rTMS sessions. (2) All of these participants provided behavioral outcome data at the primary endpoint, i.e. 1 week after completion of the TMS intervention.
Brain-derived Neurotrophic Factor (BDNF) plasma levels were measured from blood samples that were collected during the first session and the last session of TMS intervention, after a minimum of 4 hours of fasting. Higher change scores represent a better outcome.
Outcome measures
| Measure |
Placebo rTMS (Inactive)
n=9 Participants
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral DLPFC)
n=12 Participants
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=10 Participants
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Pre-post Change in Peripheral Levels of Brain-derived Neurotrophic Factor (BDNF)
|
687.17 pg/mL
Standard Deviation 2145.18
|
394.83 pg/mL
Standard Deviation 1773.65
|
1188.85 pg/mL
Standard Deviation 3513.12
|
Adverse Events
Active rTMS (Bilateral DLPFC)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Active rTMS (Bilateral LPC)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo rTMS (Inactive)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active rTMS (Bilateral DLPFC)
n=14 participants at risk
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=13 participants at risk
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Placebo rTMS (Inactive)
n=13 participants at risk
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic cancer
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Musculoskeletal and connective tissue disorders
hip fracture
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Musculoskeletal and connective tissue disorders
rotator cuff (surgerical repair)
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 2 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
Other adverse events
| Measure |
Active rTMS (Bilateral DLPFC)
n=14 participants at risk
One-third of participants will receive active rTMS to the right and left dorsolateral prefrontal cortex (DLPFC).
Active rTMS (Bilateral DLPFC): TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Active rTMS (Bilateral LPC)
n=13 participants at risk
One-third of participants will receive active rTMS to the right and left lateral parietal cortex (LPC).
Active rTMS (Bilateral LPC): TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
Placebo rTMS (Inactive)
n=13 participants at risk
One-third of participants will receive placebo/inactive rTMS, either to the DLPFC or the LPC. Those receiving placebo rTMS will serve as the control group.
Placebo rTMS (Inactive): For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
|
|---|---|---|---|
|
General disorders
Site discomfort
|
21.4%
3/14 • Number of events 3 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Gastrointestinal disorders
Toothache/TMJ pain
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Psychiatric disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
General disorders
Site pain
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
0.00%
0/13 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.
Medical Dictionary for Regulatory Activities (MedDRA)
|
Additional Information
Joy L Taylor, PhD
Veterans Affairs Palo Alto Health Care System
Phone: 650-776-3385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place