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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Mild Traumatic Brain Injury; Amnestic Mild Cognitive Impairment
• Intervention / Treatment: Device: High Definition Transcranial Direct Current Stimulation; Device: Sham HD-tDCS

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up.	Device: High Definition Transcranial Direct Current Stimulation; 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 Comparator: Sham HD-tDCS; 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.	Device: Sham HD-tDCS; Sham HD-tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, immediately post-treatment, and a 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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	Baseline, immediate post-treatment, and a 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Congressionally Directed Medical Research Programs

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): June 16, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: STU-2019-1769; CDMRP-AZ190088 (Other Grant/Funding Number: CDMRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to upload study data to the FITBIR repository system within one year of completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No