Trial · NCT04504630

Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury

NCT04504630, Not applicable, Completed, University of Texas Southwestern Medical Center; results first posted 2025-05-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury. Trials, record NCT04504630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04504630

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury
NCT number: NCT04504630
Status: Completed
Phases: Not applicable
Enrollment: 26 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury
Interventions: High Definition Transcranial Direct Current Stimulation, Sham HD-tDCS
First posted: 2020-08-07
Last updated: 2026-01-13
Results first posted: 2025-05-04

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hopkins Verbal Learning Test-Revised Total Learning	Baseline, immediately following last HD-tDCS session, and again at 3-month 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.
Primary	Hopkins Verbal Learning Test-Revised Delayed Recall	Baseline, immediately following the last HD-tDCS session, and a 3-month 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.
Primary	Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning	Baseline, immediately post-treatment, and a 3 -month 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.
Primary	Brief Visuospatial Memory Test-Revised Delayed Recall	Baseline, immediately post-treatment, and a 3-month 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.
Secondary	Phonemic Fluency	Baseline, immediately post-treatment, and a 3-month 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.
Secondary	Semantic Fluency	Baseline, immediate post-treatment, and a 3-month 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.
Secondary	Trail Making Test	Baseline, immediate post-treatment, and a 3-month 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
Secondary	Stroop Color and Word Test	Baseline, immediate post-treatment, and a 3-month 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.
Secondary	Digit Span Test	Baseline, immediate post-treatment, and a 3-month 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

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hopkins Verbal Learning Test-Revised Total Learning	Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up	4 participants were lost to follow-up	T-score on a scale	MEAN
PRIMARY	Hopkins Verbal Learning Test-Revised Delayed Recall	Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up	4 participants lost to follow-up	T-score on a scale	MEAN
PRIMARY	Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning	Baseline, immediately post-treatment, and a 3 -month follow-up	1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.	T-score on a scale	MEAN
PRIMARY	Brief Visuospatial Memory Test-Revised Delayed Recall	Baseline, immediately post-treatment, and a 3-month follow-up	1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.	T-score on a scale	MEAN
SECONDARY	Phonemic Fluency	Baseline, immediately post-treatment, and a 3-month follow-up	4 participants were lost to follow-up.	T-score on a scale	MEAN
SECONDARY	Semantic Fluency	Baseline, immediate post-treatment, and a 3-month follow-up	4 participants were lost to follow-up.	T-score on a scale	MEAN
SECONDARY	Trail Making Test	Baseline, immediate post-treatment, and a 3-month follow-up	4 participants were lost to follow-up	T-score on a scale	MEAN
SECONDARY	Stroop Color and Word Test	Baseline, immediate post-treatment, and a 3-month follow-up	4 participants were lost to follow-up	T-score on a scale	MEAN
SECONDARY	Digit Span Test	Baseline, immediate post-treatment, and a 3-month follow-up	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.	Scaled score on a scale	MEAN

Source ClinicalTrials.gov

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Hopkins Verbal Learning Test-Revised Total Learning	Active HD-tDCS	Baseline	35.8	Standard Deviation 10.4	T-score on a scale
Hopkins Verbal Learning Test-Revised Total Learning	Sham HD-tDCS	Baseline	35.9	Standard Deviation 8.0	T-score on a scale
Hopkins Verbal Learning Test-Revised Total Learning	Active HD-tDCS	Immediate Post-treatment	34.2	Standard Deviation 9.6	T-score on a scale
Hopkins Verbal Learning Test-Revised Total Learning	Sham HD-tDCS	Immediate Post-treatment	31.6	Standard Deviation 4.4	T-score on a scale
Hopkins Verbal Learning Test-Revised Total Learning	Active HD-tDCS	3 Month Follow-up	32.7	Standard Deviation 8.8	T-score on a scale
Hopkins Verbal Learning Test-Revised Total Learning	Sham HD-tDCS	3 Month Follow-up	37.1	Standard Deviation 17.2	T-score on a scale
Hopkins Verbal Learning Test-Revised Delayed Recall	Active HD-tDCS	Baseline	30.1	Standard Deviation 12.8	T-score on a scale
Hopkins Verbal Learning Test-Revised Delayed Recall	Sham HD-tDCS	Baseline	31.0	Standard Deviation 14.1	T-score on a scale
Hopkins Verbal Learning Test-Revised Delayed Recall	Active HD-tDCS	Immediate Post-treatment	27.7	Standard Deviation 11.4	T-score on a scale
Hopkins Verbal Learning Test-Revised Delayed Recall	Sham HD-tDCS	Immediate Post-treatment	26.9	Standard Deviation 8.2	T-score on a scale

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Assigned to Treatment	STARTED	Active HD-tDCS	18
Assigned to Treatment	STARTED	Sham HD-tDCS	8
Assigned to Treatment	COMPLETED	Active HD-tDCS	16
Assigned to Treatment	COMPLETED	Sham HD-tDCS	8
Assigned to Treatment	NOT COMPLETED	Active HD-tDCS	2
Assigned to Treatment	NOT COMPLETED	Sham HD-tDCS	0
Started Treatment	STARTED	Active HD-tDCS	16
Started Treatment	STARTED	Sham HD-tDCS	8
Started Treatment	COMPLETED	Active HD-tDCS	16
Started Treatment	COMPLETED	Sham HD-tDCS	8

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea and Vomiting	Gastrointestinal disorders	Active HD-tDCS	0	16	0
other	Nausea and Vomiting	Gastrointestinal disorders	Sham HD-tDCS	1	8	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active HD-tDCS	0	16
Total, all-cause mortality	Sham HD-tDCS	0	8
Total, other adverse events	Active HD-tDCS	0	16
Total, other adverse events	Sham HD-tDCS	1	8
Total, serious adverse events	Active HD-tDCS	0	16
Total, serious adverse events	Sham HD-tDCS	0	8

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active HD-tDCS vs Sham HD-tDCS: deaths from any cause	Trial comparisons
Active HD-tDCS vs Sham HD-tDCS: serious adverse events	Trial comparisons

Tests7

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Verbal Learning	Primary outcome	ConductCognition
Category Fluency	Secondary outcome	ConductCognition
Digit Span Test	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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