Trial Outcomes & Findings for Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury (NCT NCT04504630)
NCT ID: NCT04504630
Last Updated: 2026-01-13
Results Overview
Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 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 0-36. 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 episodic memory performance.
COMPLETED
NA
26 participants
Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up
2026-01-13
Participant Flow
Participant milestones
| Measure |
Active HD-tDCS
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Assigned to Treatment
STARTED
|
18
|
8
|
|
Assigned to Treatment
COMPLETED
|
16
|
8
|
|
Assigned to Treatment
NOT COMPLETED
|
2
|
0
|
|
Started Treatment
STARTED
|
16
|
8
|
|
Started Treatment
COMPLETED
|
16
|
8
|
|
Started Treatment
NOT COMPLETED
|
0
|
0
|
|
Follow-Up at 3 Months
STARTED
|
16
|
8
|
|
Follow-Up at 3 Months
COMPLETED
|
13
|
7
|
|
Follow-Up at 3 Months
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Active HD-tDCS
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Assigned to Treatment
Withdrawal by Subject
|
2
|
0
|
|
Follow-Up at 3 Months
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury
Baseline characteristics by cohort
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 5.6 • n=210 Participants
|
72.5 years
STANDARD_DEVIATION 8.1 • n=19 Participants
|
71.0 years
STANDARD_DEVIATION 6.4 • n=123 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
8 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=210 Participants
|
6 Participants
n=19 Participants
|
16 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=210 Participants
|
8 Participants
n=19 Participants
|
23 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=210 Participants
|
8 Participants
n=19 Participants
|
24 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=210 Participants
|
8 participants
n=19 Participants
|
24 participants
n=123 Participants
|
|
Time since diagnosis
|
2.2 years
STANDARD_DEVIATION 1.8 • n=210 Participants
|
1.5 years
STANDARD_DEVIATION 1.4 • n=19 Participants
|
2.0 years
STANDARD_DEVIATION 1.7 • n=123 Participants
|
|
Education
|
17.0 years
STANDARD_DEVIATION 2.2 • n=210 Participants
|
17.4 years
STANDARD_DEVIATION 1.6 • n=19 Participants
|
17.1 years
STANDARD_DEVIATION 2.0 • n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-upPopulation: 4 participants were lost to follow-up
Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 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 0-36. 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 episodic memory performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Hopkins Verbal Learning Test-Revised Total Learning
Baseline
|
35.8 T-score on a scale
Standard Deviation 10.4
|
35.9 T-score on a scale
Standard Deviation 8.0
|
|
Hopkins Verbal Learning Test-Revised Total Learning
Immediate Post-treatment
|
34.2 T-score on a scale
Standard Deviation 9.6
|
31.6 T-score on a scale
Standard Deviation 4.4
|
|
Hopkins Verbal Learning Test-Revised Total Learning
3 Month Follow-up
|
32.7 T-score on a scale
Standard Deviation 8.8
|
37.1 T-score on a scale
Standard Deviation 17.2
|
PRIMARY outcome
Timeframe: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-upPopulation: 4 participants lost to follow-up
Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 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 0-36. 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 episodic memory performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Hopkins Verbal Learning Test-Revised Delayed Recall
Baseline
|
30.1 T-score on a scale
Standard Deviation 12.8
|
31.0 T-score on a scale
Standard Deviation 14.1
|
|
Hopkins Verbal Learning Test-Revised Delayed Recall
Immediate Post-treatment
|
27.7 T-score on a scale
Standard Deviation 11.4
|
26.9 T-score on a scale
Standard Deviation 8.2
|
|
Hopkins Verbal Learning Test-Revised Delayed Recall
3-Month Follow-up
|
26.9 T-score on a scale
Standard Deviation 10.5
|
32.4 T-score on a scale
Standard Deviation 17.9
|
PRIMARY outcome
Timeframe: Baseline, immediately post-treatment, and a 3 -month follow-upPopulation: 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.
Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement 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 episodic memory performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
Baseline
|
33.0 T-score on a scale
Standard Deviation 10.0
|
29.1 T-score on a scale
Standard Deviation 8.9
|
|
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
Immediate Post-treatment
|
32.3 T-score on a scale
Standard Deviation 10.4
|
33.3 T-score on a scale
Standard Deviation 7.0
|
|
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
3-Month Follow-up
|
33.8 T-score on a scale
Standard Deviation 8.1
|
34.1 T-score on a scale
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: Baseline, immediately post-treatment, and a 3-month follow-upPopulation: 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.
Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement 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 episodic memory performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Brief Visuospatial Memory Test-Revised Delayed Recall
Baseline
|
32.6 T-score on a scale
Standard Deviation 9.8
|
32.4 T-score on a scale
Standard Deviation 9.4
|
|
Brief Visuospatial Memory Test-Revised Delayed Recall
Immediate Post-treatment
|
32.4 T-score on a scale
Standard Deviation 11.9
|
32.0 T-score on a scale
Standard Deviation 8.6
|
|
Brief Visuospatial Memory Test-Revised Delayed Recall
3-Month Follow-up
|
31.6 T-score on a scale
Standard Deviation 12.9
|
32.4 T-score on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline, immediately post-treatment, and a 3-month follow-upPopulation: 4 participants were lost to follow-up.
The 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.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Phonemic Fluency
Baseline
|
45.8 T-score on a scale
Standard Deviation 9.1
|
49.1 T-score on a scale
Standard Deviation 13.9
|
|
Phonemic Fluency
Immediately Post-treatment
|
46.3 T-score on a scale
Standard Deviation 5.8
|
53.0 T-score on a scale
Standard Deviation 14.1
|
|
Phonemic Fluency
3-Month Follow-up
|
49.1 T-score on a scale
Standard Deviation 8.1
|
54.6 T-score on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Baseline, immediate post-treatment, and a 3-month follow-upPopulation: 4 participants were lost to follow-up.
The semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals as possible within 1 minute. The outcome measure for this task is the total number of correct responses, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Semantic Fluency
Baseline
|
38.4 T-score on a scale
Standard Deviation 14.7
|
37.4 T-score on a scale
Standard Deviation 15.4
|
|
Semantic Fluency
Immediate Post-treatment
|
38.6 T-score on a scale
Standard Deviation 16.3
|
42.2 T-score on a scale
Standard Deviation 17.8
|
|
Semantic Fluency
3-Month Follow-up
|
37.3 T-score on a scale
Standard Deviation 13.8
|
38.4 T-score on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Baseline, immediate post-treatment, and a 3-month follow-upPopulation: 4 participants were lost to follow-up
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
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Trail Making Test
Baseline
|
41.6 T-score on a scale
Standard Deviation 15.9
|
41.9 T-score on a scale
Standard Deviation 13.3
|
|
Trail Making Test
Immediate Post-treatment
|
45.7 T-score on a scale
Standard Deviation 10.2
|
44.1 T-score on a scale
Standard Deviation 16.4
|
|
Trail Making Test
3-Month Follow-up
|
47.8 T-score on a scale
Standard Deviation 17.6
|
39.1 T-score on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline, immediate post-treatment, and a 3-month follow-upPopulation: 4 participants were lost to follow-up
The Stroop Color and Word Test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete 3 conditions, involving word reading, color naming, and response inhibition. The outcome measure for this task was the response inhibition trial, which is scored as the total correct items completed in the administration time of 45 seconds, ranging from 0-100. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance.
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Stroop Color and Word Test
Baseline
|
38.8 T-score on a scale
Standard Deviation 6.9
|
39.1 T-score on a scale
Standard Deviation 10.3
|
|
Stroop Color and Word Test
Immediate Post-treatment
|
41.6 T-score on a scale
Standard Deviation 9.8
|
40.0 T-score on a scale
Standard Deviation 9.6
|
|
Stroop Color and Word Test
3-Month Follow-up
|
39.9 T-score on a scale
Standard Deviation 12.4
|
37.9 T-score on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, immediate post-treatment, and a 3-month follow-upPopulation: 1 participant did not complete the Digit Span Test in the active HD-tDCS group at the 3-month follow-up. 4 participants were lost to follow-up.
The Wechsler Adult Intelligence Scale-4 Digit Span Test measures simple attention and working memory. The examiner reads aloud a series of numbers of increasing length, and individuals are required to repeat each series across 3 separate conditions, involving forwards, backwards, and in sequence. Each trial is scored as incorrect (0) or correct (1), and the total number of correct trials across the 3 conditions are summed, ranging from 0-48. Scores were converted to standardized scores (scaled-scores) using normative data, ranging from 1-19. Higher scores reflect better episodic memory performance
Outcome measures
| Measure |
Active HD-tDCS
n=16 Participants
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 Participants
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Digit Span Test
Baseline
|
10.8 Scaled score on a scale
Standard Deviation 2.0
|
9.8 Scaled score on a scale
Standard Deviation 1.8
|
|
Digit Span Test
Immediate Post-treatment
|
10.6 Scaled score on a scale
Standard Deviation 1.7
|
10.4 Scaled score on a scale
Standard Deviation 1.8
|
|
Digit Span Test
3-Month Follow-up
|
10.8 Scaled score on a scale
Standard Deviation 2.0
|
9.4 Scaled score on a scale
Standard Deviation 2.1
|
Adverse Events
Active HD-tDCS
Sham HD-tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active HD-tDCS
n=16 participants at risk
Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks.
|
Sham HD-tDCS
n=8 participants at risk
Participants will receive 10 sessions of sham stimulation across 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
0.00%
0/16 • Adverse events were monitored from the start of assigned treatments (1 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 3-month follow-up visit.
|
12.5%
1/8 • Number of events 1 • Adverse events were monitored from the start of assigned treatments (1 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 3-month follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place