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

NCT04504630 | Completed Results DMC

• 2 other identifiers: STU-2019-1769CDMRP-AZ190088
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Phonemic Fluency

  Baseline, immediately post-treatment, and a 3-month follow-up

• Semantic Fluency

  Baseline, immediate post-treatment, and a 3-month follow-up

• Trail Making Test

  Baseline, immediate post-treatment, and a 3-month follow-up

• Stroop Color and Word Test

  Baseline, immediate post-treatment, and a 3-month follow-up

• Digit Span Test

  Baseline, immediate post-treatment, and a 3-month follow-up

Study Arms (2)

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.

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.

Device: Sham HD-tDCS

Interventions

High Definition Transcranial Direct Current Stimulation DEVICE

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).

Active HD-tDCS

Sham HD-tDCS DEVICE

Sham HD-tDCS

Sham HD-tDCS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Results Point of Contact

• Title: Christian LoBue, PhD
• Organization: UT Southwestern Medical Center

Christian.LoBue@utsw.edu

2146484658

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: December 5, 2020
• Primary Completion: June 16, 2024
• Study Completion: January 30, 2025
• Last Updated: January 13, 2026
• Results First Posted: May 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)