Amnestic Mild Cognitive ImpairmentNCT04504630

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

A study testing High Definition Transcranial Direct Current Stimulation in people with Amnestic Mild Cognitive Impairment and Traumatic Brain Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury
What is being tested?: High Definition Transcranial Direct Current Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2020to 30 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 50 and older
Native English speakers
12 years of education or higher
Active diagnosis of aMCI
History of TBI based on VA/DOD criteria

Who cannot join

TBI within the past 2 years
Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
Lifetime history of epilepsy
Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
Substance use disorder
Has metal fragments in head
Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI

The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.

Conditions: Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury
Being tested: High Definition Transcranial Direct Current Stimulation, Sham HD-tDCS
Medical subject headings: Brain Injuries, Traumatic, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Definition Transcranial Direct Current StimulationDevice
This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).
Sham HD-tDCSDevice
Sham HD-tDCS

Study groups in NCT04504630
Study group	Role	What they receive
Active HD-tDCS	Active comparator	Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up. Receives: Device: High Definition Transcranial Direct Current Stimulation
Sham HD-tDCS	Sham comparator	Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up. Receives: Device: Sham HD-tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Hopkins Verbal Learning Test-Revised Total Learning
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.
Measured: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up
Hopkins Verbal Learning Test-Revised Delayed Recall
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.
Measured: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
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.
Measured: Baseline, immediately post-treatment, and a 3 -month follow-up
Brief Visuospatial Memory Test-Revised Delayed Recall
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.
Measured: Baseline, immediately post-treatment, and a 3-month follow-up

Secondary outcomes (5)

Phonemic Fluency
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.
Measured: Baseline, immediately post-treatment, and a 3-month follow-up
Semantic Fluency
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.
Measured: Baseline, immediate post-treatment, and a 3-month follow-up
Trail Making Test
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
Measured: Baseline, immediate post-treatment, and a 3-month follow-up
Stroop Color and Word Test
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.
Measured: Baseline, immediate post-treatment, and a 3-month follow-up
Digit Span Test
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
Measured: Baseline, immediate post-treatment, and a 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 202030 Jan 2025

First posted7 Aug 2020
Study start5 Dec 2020
Primary completion16 Jun 2024
Study completion30 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04504630
Sponsor's protocol ID: STU-2019-1769
Other IDs: CDMRP-AZ190088
Status last verified: Dec 2025
First submitted: 5 Aug 2020
Last updated: 13 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: There is a plan to upload study data to the FITBIR repository system within one year of completion.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amnestic Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI
ClinicalTrials.gov ID: NCT04504630
Acronym / sponsor ID: STU-2019-1769
Conditions: Amnestic Mild Cognitive Impairment, Traumatic Brain Injury, Mild Traumatic Brain Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Congressionally Directed Medical Research Programs
Study start: 5 Dec 2020 (actual)
Primary completion: 16 Jun 2024 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 4 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active HD-tDCS	Active comparator	Device: High Definition Transcranial Direct Current StimulationParticipants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.
Sham HD-tDCS	Sham comparator	Device: Sham HD-tDCSParticipants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 50 and older
Native English speakers
12 years of education or higher
Active diagnosis of aMCI
History of TBI based on VA/DOD criteria

Key exclusion criteria (7 listed)

TBI within the past 2 years
Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
Lifetime history of epilepsy
Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
Substance use disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Definition Transcranial Direct Current StimulationThis wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).	Device	Active HD-tDCS
Sham HD-tDCSSham HD-tDCS	Device	Sham HD-tDCS

Primary outcome

Hopkins Verbal Learning Test-Revised Total Learning
Time frame: 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.
Hopkins Verbal Learning Test-Revised Delayed Recall
Time frame: 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.
Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning
Time frame: 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.
Brief Visuospatial Memory Test-Revised Delayed Recall
Time frame: 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.

5 secondary outcomes

Phonemic Fluency
Time frame: Baseline, immediately post-treatment, and a 3-month follow-up
Semantic Fluency
Time frame: Baseline, immediate post-treatment, and a 3-month follow-up
Trail Making Test
Time frame: Baseline, immediate post-treatment, and a 3-month follow-up
Stroop Color and Word Test
Time frame: Baseline, immediate post-treatment, and a 3-month follow-up
Digit Span Test
Time frame: Baseline, immediate post-treatment, and a 3-month follow-up

Results and safety

Results posted to the registry on 4 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active HD-tDCS	18	16
Sham HD-tDCS	8	8

Primary outcome: Hopkins Verbal Learning Test-Revised Total Learning

Time frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up. Mean (Standard Deviation). Unit: T-score on a scale

Measure	Active HD-tDCS n = 16	Sham HD-tDCS n = 8
Baseline	35.8 (10.4)	35.9 (8.0)
Immediate Post-treatment	34.2 (9.6)	31.6 (4.4)
3 Month Follow-up	32.7 (8.8)	37.1 (17.2)

Population analysed: 4 participants were lost to follow-up

Primary outcome: Hopkins Verbal Learning Test-Revised Delayed Recall

Time frame: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up. Mean (Standard Deviation). Unit: T-score on a scale

Measure	Active HD-tDCS n = 16	Sham HD-tDCS n = 8
Baseline	30.1 (12.8)	31.0 (14.1)
Immediate Post-treatment	27.7 (11.4)	26.9 (8.2)
3-Month Follow-up	26.9 (10.5)	32.4 (17.9)

Population analysed: 4 participants lost to follow-up

Primary outcome: Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning

Time frame: Baseline, immediately post-treatment, and a 3 -month follow-up. Mean (Standard Deviation). Unit: T-score on a scale

Measure	Active HD-tDCS n = 16	Sham HD-tDCS n = 8
Baseline	33.0 (10.0)	29.1 (8.9)
Immediate Post-treatment	32.3 (10.4)	33.3 (7.0)
3-Month Follow-up	33.8 (8.1)	34.1 (12.0)

Population analysed: 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.

Primary outcome: Brief Visuospatial Memory Test-Revised Delayed Recall

Time frame: Baseline, immediately post-treatment, and a 3-month follow-up. Mean (Standard Deviation). Unit: T-score on a scale

Measure	Active HD-tDCS n = 16	Sham HD-tDCS n = 8
Baseline	32.6 (9.8)	32.4 (9.4)
Immediate Post-treatment	32.4 (11.9)	32.0 (8.6)
3-Month Follow-up	31.6 (12.9)	32.4 (11.1)

Population analysed: 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active HD-tDCS	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Sham HD-tDCS	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. There is a plan to upload study data to the FITBIR repository system within one year of completion.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hopkins Verbal Learning Test-Revised Total Learning (time frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04504630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.