Trial Outcomes & Findings for Using TMS to Increase Executive Function in Older Adults (NCT NCT02767323)
NCT ID: NCT02767323
Last Updated: 2021-04-05
Results Overview
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS. The accuracy provided below are the ones obtained in the hardest condition of the working memory task.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
During the rTMS session, on average 2 hours per visit.
Results posted on
2021-04-05
Participant Flow
Participant milestones
| Measure |
Active or Sham rTMS Over the DLPFC (Aim1a)
excitatory rTMS applied over the DLPFC (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the Parietal Cortex (Aim1b)
excitatory rTMS applied over the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
Active/Sham rTMS Over DLPFC (Aim1a), Then Active/Sham rTMS Over DLPFC and Parietal Cortex (Aim1c)
excitatory rTMS applied over the DLPFC (fMRI-guided) and the Parietal cortex
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
42
|
58
|
1
|
|
Overall Study
COMPLETED
|
49
|
17
|
28
|
1
|
|
Overall Study
NOT COMPLETED
|
34
|
25
|
30
|
0
|
Reasons for withdrawal
| Measure |
Active or Sham rTMS Over the DLPFC (Aim1a)
excitatory rTMS applied over the DLPFC (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the Parietal Cortex (Aim1b)
excitatory rTMS applied over the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
Active/Sham rTMS Over DLPFC (Aim1a), Then Active/Sham rTMS Over DLPFC and Parietal Cortex (Aim1c)
excitatory rTMS applied over the DLPFC (fMRI-guided) and the Parietal cortex
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
5
|
13
|
0
|
|
Overall Study
Contraindication, moving during the scan, low behavior, or Covid-19
|
17
|
20
|
17
|
0
|
Baseline Characteristics
Using TMS to Increase Executive Function in Older Adults
Baseline characteristics by cohort
| Measure |
Active or Sham rTMS Over the DLPFC (Aim1a)
n=83 Participants
excitatory rTMS applied over the DLPFC (fMRI-guided)
rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the Parietal Cortex (Aim1b)
n=42 Participants
excitatory rTMS applied over the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
n=58 Participants
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC (Aim1a), Then Active or Sham rTMS Over the DLPFC (Aim1c)
n=1 Participants
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz. Active and Sham rTMS will be tested in a within subject design
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
134 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
|
Age, Continuous
|
40.85 years
STANDARD_DEVIATION 23.09 • n=93 Participants
|
67.26 years
STANDARD_DEVIATION 6.23 • n=4 Participants
|
23.65 years
STANDARD_DEVIATION 4.14 • n=27 Participants
|
28 years
STANDARD_DEVIATION 1.4 • n=483 Participants
|
41.31 years
STANDARD_DEVIATION 22.47 • n=36 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
102 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
82 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
132 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
184 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: During the rTMS session, on average 2 hours per visit.Population: Subjects who completed the study. Data not collected on five subjects.
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS. The accuracy provided below are the ones obtained in the hardest condition of the working memory task.
Outcome measures
| Measure |
Active or Sham rTMS Over the DLPFC (Aim1a)
n=46 Participants
excitatory rTMS applied over the DLPFC (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the Parietal Cortex (Aim1b)
n=15 Participants
excitatory rTMS applied over the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
n=29 Participants
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
|---|---|---|---|
|
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Accuracy (in Percentage)
Active rTMS
|
50.43 percentage of accuracy
Standard Deviation 7.37
|
55.42 percentage of accuracy
Standard Deviation 5.50
|
83.93 percentage of accuracy
Standard Deviation 8.09
|
|
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Accuracy (in Percentage)
Sham rTMS
|
46.49 percentage of accuracy
Standard Deviation 7.35
|
57.76 percentage of accuracy
Standard Deviation 5.70
|
83.27 percentage of accuracy
Standard Deviation 10.88
|
PRIMARY outcome
Timeframe: During the rTMS session, on average 2 hours per visitPopulation: Subjects who completed the study. Data not collected on five subjects.
Reaction Time of correct response (in ms) will be assessed to evaluate the acute effect of rTMS. The reaction times provided below are the ones obtained in the hardest condition of the working memory task.
Outcome measures
| Measure |
Active or Sham rTMS Over the DLPFC (Aim1a)
n=46 Participants
excitatory rTMS applied over the DLPFC (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the Parietal Cortex (Aim1b)
n=15 Participants
excitatory rTMS applied over the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used Active and Sham rTMS will be tested in a within subject design
|
Active or Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
n=29 Participants
excitatory rTMS applied over the the DLPFC and the parietal cortex (fMRI-guided)
rTMS: excitatory 5Hz rTMS will be used. Active and Sham rTMS will be tested in a within subject design
|
|---|---|---|---|
|
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Reaction Time of Correct Response (in ms)
Active rTMS
|
2368 ms
Standard Deviation 335
|
2214 ms
Standard Deviation 231
|
1911 ms
Standard Deviation 356
|
|
Acute Effect of a rTMS Session on the Performance for a Working Memory Task, as Measured by Reaction Time of Correct Response (in ms)
Sham rTMS
|
2388 ms
Standard Deviation 345
|
2224 ms
Standard Deviation 180
|
1924 ms
Standard Deviation 332
|
Adverse Events
Active rTMS Over the DLPFC (Aim1a)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS Over the DLPFC (Aim1a)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active rTMS Over the Parietal Cortex (Aim 1b)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS Over the Parietal Cortex (Aim 1b)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS Over the DLPFC and the Parietal Cortex (Aim 1c)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active rTMS Over the DLPFC (Aim1a) Then Active rTMS Over the DLPFC and Parietal Cortex(Aim1c)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS Over the DLPFC (Aim1a) Then Sham rTMS Over the DLPFC and Parietal Cortex(Aim1c)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place