Trial Outcomes & Findings for Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia (NCT NCT05270408)
NCT ID: NCT05270408
Last Updated: 2025-03-05
Results Overview
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.
COMPLETED
NA
33 participants
Baseline, immediately following last treatment session, and 2-months post treatment
2025-03-05
Participant Flow
Participant milestones
| Measure |
Sham Group
Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.
Sham Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.
|
Active Stimulation at 1mA
Participants will receive 1 mA active HD-tDCS for 20 minutes.
Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.
|
Active Stimulation at 2mA
Participants will receive 2 mA active HD-tDCS for 20 minutes.
Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.
|
|---|---|---|---|
|
Assigned to Treatment
STARTED
|
6
|
13
|
14
|
|
Assigned to Treatment
Assigned to Treatment With Mild Cognitive Impairment
|
1
|
3
|
0
|
|
Assigned to Treatment
Assigned to Treatment With Alzheimer Dementia
|
5
|
10
|
14
|
|
Assigned to Treatment
COMPLETED
|
6
|
13
|
14
|
|
Assigned to Treatment
NOT COMPLETED
|
0
|
0
|
0
|
|
Started Treatment
STARTED
|
5
|
12
|
13
|
|
Started Treatment
Started Treatment With Diagnosis of Mild Cognitive Impairment
|
0
|
3
|
0
|
|
Started Treatment
Started Treatment With Diagnosis of Alzheimer Dementia
|
5
|
9
|
13
|
|
Started Treatment
COMPLETED
|
5
|
12
|
9
|
|
Started Treatment
NOT COMPLETED
|
0
|
0
|
4
|
|
Follow-Up at 2 Months
STARTED
|
5
|
12
|
9
|
|
Follow-Up at 2 Months
COMPLETED
|
4
|
12
|
9
|
|
Follow-Up at 2 Months
NOT COMPLETED
|
1
|
0
|
0
|
|
Analysis - Primary Outcomes Available
STARTED
|
5
|
12
|
9
|
|
Analysis - Primary Outcomes Available
Outcomes Available With Mild Cognitive Impairment
|
0
|
2
|
0
|
|
Analysis - Primary Outcomes Available
Outcomes Available With Alzheimer Dementia
|
5
|
10
|
9
|
|
Analysis - Primary Outcomes Available
COMPLETED
|
5
|
9
|
9
|
|
Analysis - Primary Outcomes Available
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Sham Group
Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.
Sham Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.
|
Active Stimulation at 1mA
Participants will receive 1 mA active HD-tDCS for 20 minutes.
Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.
|
Active Stimulation at 2mA
Participants will receive 2 mA active HD-tDCS for 20 minutes.
Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.
|
|---|---|---|---|
|
Started Treatment
Withdrawal by Subject
|
0
|
0
|
3
|
|
Started Treatment
Adverse Event
|
0
|
0
|
1
|
|
Follow-Up at 2 Months
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Data missing for 3 participants
Baseline characteristics by cohort
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
74.0 years
STANDARD_DEVIATION 9.5 • n=9 Participants
|
68.4 years
STANDARD_DEVIATION 7.8 • n=9 Participants
|
70.8 years
STANDARD_DEVIATION 8.8 • n=23 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
11 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
12 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
22 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
21 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
23 participants
n=23 Participants
|
|
Education
|
16.0 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.7 • n=9 Participants
|
14.4 years
STANDARD_DEVIATION 2.4 • n=9 Participants
|
14.7 years
STANDARD_DEVIATION 2.3 • n=23 Participants
|
|
Time since diagnosis
|
2.3 years
STANDARD_DEVIATION 1.0 • n=5 Participants • Data missing for 3 participants
|
3.4 years
STANDARD_DEVIATION 3.3 • n=7 Participants • Data missing for 3 participants
|
1.1 years
STANDARD_DEVIATION 1.0 • n=8 Participants • Data missing for 3 participants
|
2.3 years
STANDARD_DEVIATION 2.4 • n=20 Participants • Data missing for 3 participants
|
PRIMARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT total learning Baseline
|
13.8 T-score on a scale
Standard Deviation 10.4
|
17.8 T-score on a scale
Standard Deviation 11.2
|
18.0 T-score on a scale
Standard Deviation 10.3
|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT Total Learning Immediate post-treatment
|
13.4 T-score on a scale
Standard Deviation 11.7
|
21.0 T-score on a scale
Standard Deviation 9.7
|
21.9 T-score on a scale
Standard Deviation 12.8
|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT Total Learning 2 months
|
16.3 T-score on a scale
Standard Deviation 5.6
|
23.3 T-score on a scale
Standard Deviation 13.8
|
17.2 T-score on a scale
Standard Deviation 11.0
|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT Delayed Baseline
|
20.6 T-score on a scale
Standard Deviation 0.9
|
24.4 T-score on a scale
Standard Deviation 6.1
|
22.3 T-score on a scale
Standard Deviation 2.7
|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT Delayed Immediate Post-treatment
|
21.2 T-score on a scale
Standard Deviation 1.8
|
24.0 T-score on a scale
Standard Deviation 6.2
|
22.3 T-score on a scale
Standard Deviation 1.8
|
|
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
RAVLT Delayed 2 Months
|
21.8 T-score on a scale
Standard Deviation 1.5
|
25.7 T-score on a scale
Standard Deviation 10.1
|
21.1 T-score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up
The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Delayed Baseline
|
21.4 T-score on a scale
Standard Deviation 3.1
|
26.9 T-score on a scale
Standard Deviation 12.7
|
20.3 T-score on a scale
Standard Deviation 1.0
|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Total Learning Baseline
|
20.8 T-score on a scale
Standard Deviation 1.1
|
24.2 T-score on a scale
Standard Deviation 8.9
|
21.7 T-score on a scale
Standard Deviation 3.1
|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Total Learning Immediate Post-treatment
|
22.8 T-score on a scale
Standard Deviation 2.6
|
24.2 T-score on a scale
Standard Deviation 5.2
|
21.1 T-score on a scale
Standard Deviation 2.0
|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Total Learning 2 Months
|
20.0 T-score on a scale
Standard Deviation 0.0
|
24.6 T-score on a scale
Standard Deviation 9.9
|
20.7 T-score on a scale
Standard Deviation 1.0
|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Delayed Immediate Posttreatment
|
20.6 T-score on a scale
Standard Deviation 1.3
|
24.7 T-score on a scale
Standard Deviation 10.1
|
22.8 T-score on a scale
Standard Deviation 5.2
|
|
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT Delayed 2 Months
|
20.3 T-score on a scale
Standard Deviation 0.5
|
25.4 T-score on a scale
Standard Deviation 11.5
|
21.1 T-score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up
The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Boston Naming Test Short Form
Baseline
|
30.6 T-score on a scale
Standard Deviation 16.2
|
31.6 T-score on a scale
Standard Deviation 8.1
|
30.1 T-score on a scale
Standard Deviation 9.0
|
|
Change in Score on the Boston Naming Test Short Form
Immediate Posttreatment
|
30.4 T-score on a scale
Standard Deviation 14.9
|
31.5 T-score on a scale
Standard Deviation 9.0
|
31.9 T-score on a scale
Standard Deviation 8.1
|
|
Change in Score on the Boston Naming Test Short Form
2 Months
|
39.5 T-score on a scale
Standard Deviation 27.7
|
32.1 T-score on a scale
Standard Deviation 8.5
|
27.6 T-score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up
The DKEFS phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
Baseline
|
39.0 T-score on a scale
Standard Deviation 13.7
|
37.5 T-score on a scale
Standard Deviation 8.7
|
32.7 T-score on a scale
Standard Deviation 14.5
|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
Immediate Posttreatment
|
33.6 T-score on a scale
Standard Deviation 14.9
|
40.4 T-score on a scale
Standard Deviation 9.7
|
35.9 T-score on a scale
Standard Deviation 14.2
|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
2 Months
|
35.3 T-score on a scale
Standard Deviation 11.0
|
41.7 T-score on a scale
Standard Deviation 9.9
|
32.1 T-score on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up
The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
Baseline
|
24.2 T-score on a scale
Standard Deviation 10.6
|
28.1 T-score on a scale
Standard Deviation 6.4
|
24.9 T-score on a scale
Standard Deviation 6.0
|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
Immediate Posttreatment
|
25.0 T-score on a scale
Standard Deviation 15.7
|
30.9 T-score on a scale
Standard Deviation 8.7
|
22.8 T-score on a scale
Standard Deviation 5.6
|
|
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
2 Months
|
24.5 T-score on a scale
Standard Deviation 9.0
|
30.2 T-score on a scale
Standard Deviation 13.1
|
23.9 T-score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points.
The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Trail Making Test
Baseline
|
22.3 T-score on a scale
Standard Deviation 19.1
|
31.3 T-score on a scale
Standard Deviation 17.4
|
22.8 T-score on a scale
Standard Deviation 9.9
|
|
Change in Score on the Trail Making Test
Immediate Posttreatment
|
28.0 T-score on a scale
Standard Deviation 27.4
|
24.4 T-score on a scale
Standard Deviation 14.8
|
20.6 T-score on a scale
Standard Deviation 13.2
|
|
Change in Score on the Trail Making Test
2 Months
|
24.5 T-score on a scale
Standard Deviation 20.4
|
28.5 T-score on a scale
Standard Deviation 15.8
|
19.7 T-score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: One participant lost to follow-up. Data missing for this measure on one participant in active 2 mA group.
The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the Southwestern Assessment of Processing Speed
Baseline
|
27.6 T-score on a scale
Standard Deviation 7.7
|
34.0 T-score on a scale
Standard Deviation 14.0
|
26.1 T-score on a scale
Standard Deviation 5.5
|
|
Change in Score on the Southwestern Assessment of Processing Speed
Immediate Posttreatment
|
30.2 T-score on a scale
Standard Deviation 10.1
|
31.0 T-score on a scale
Standard Deviation 10.0
|
27.9 T-score on a scale
Standard Deviation 8.8
|
|
Change in Score on the Southwestern Assessment of Processing Speed
2 Months
|
27.8 T-score on a scale
Standard Deviation 6.8
|
30.8 T-score on a scale
Standard Deviation 9.3
|
29.1 T-score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, immediately following last treatment session, and 2-months post treatmentPopulation: Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points.
The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Outcome measures
| Measure |
Sham Group
n=5 Participants
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=9 Participants
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=9 Participants
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Change in Score on the DKEFS Color-Word Interference Test
Baseline
|
35.5 T-score on a scale
Standard Deviation 21.8
|
25.1 T-score on a scale
Standard Deviation 10.6
|
35.0 T-score on a scale
Standard Deviation 14.4
|
|
Change in Score on the DKEFS Color-Word Interference Test
Immediate Posttreatment
|
29.7 T-score on a scale
Standard Deviation 20.2
|
30.3 T-score on a scale
Standard Deviation 12.9
|
34.2 T-score on a scale
Standard Deviation 13.8
|
|
Change in Score on the DKEFS Color-Word Interference Test
2 Months
|
25.0 T-score on a scale
Standard Deviation 14.0
|
28.3 T-score on a scale
Standard Deviation 14.3
|
36.4 T-score on a scale
Standard Deviation 14.0
|
Adverse Events
Sham Group
Active Stimulation at 1mA
Active Stimulation at 2mA
Serious adverse events
| Measure |
Sham Group
n=5 participants at risk
sham HD-tDCS for 20 minutes, meaning no stimulation.
|
Active Stimulation at 1mA
n=12 participants at risk
1 mA active HD-tDCS for 20 minutes.
|
Active Stimulation at 2mA
n=13 participants at risk
2 mA active HD-tDCS for 20 minutes.
|
|---|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.00%
0/5 • Adverse events were monitored from the start of assigned treatments (1 mA, 2 mA, and sham) through study completion. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month visit.
|
0.00%
0/12 • Adverse events were monitored from the start of assigned treatments (1 mA, 2 mA, and sham) through study completion. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month visit.
|
7.7%
1/13 • Number of events 1 • Adverse events were monitored from the start of assigned treatments (1 mA, 2 mA, and sham) through study completion. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 2-month visit.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place