Actively Recruiting

Phase 2
Age: 55Years +
All Genders
ID05446584

Pathways Relating Amnestic Mild Cognitive Impairment to a History of Mild Traumatic Brain Injury Using High Definition Transcranial Direct Current Stimulation

Led by University of Texas Southwestern Medical Center · Updated on 2026-05-06

75

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether biological changes in amnestic mild cognitive impairment (aMCI) relate to a history of mild traumatic brain injury (mTBI). This Phase 2 study includes participants with aMCI who either have or do not have a history of mTBI. The goal is to understand how brain stimulation and blood biomarkers might reveal differences linked to past mTBI in this population. Participants will undergo three different conditions of high definition transcranial direct current stimulation (HD-tDCS) applied via electrodes placed in a 4x1 ring configuration. The conditions include active stimulation to the frontal region, active stimulation to the left temporal region, and a sham (placebo) control. Each condition involves 30 minutes of stimulation at 2 mA or sham, delivered over three consecutive days. The order of these conditions is randomized and counterbalanced, with 14-day breaks between each. Each participant will complete ten study visits, starting with a blood draw and baseline memory tests. Memory assessments will be repeated immediately after each stimulation condition to measure changes. Researchers will also monitor executive function using specific tests. The primary outcome is the change in memory test scores before and after stimulation. Participants will be closely monitored throughout the trial, which includes multiple assessments over several weeks.

CONDITIONS

Brief Title

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active diagnosis of amnestic mild cognitive impairment
  • Presence of a mild traumatic brain injury history for the mTBI+ group; absence of mTBI history for control group
  • Female and male subjects
  • All races/ethnicities
  • Age 55 years and older
  • Fluent in English
Not Eligible

You will not qualify if you...

  • Mild traumatic brain injury within past year
  • Lifetime history of moderate or severe brain injury
  • Lifetime major neurologic syndromes such as stroke, epilepsy, or brain tumor
  • Lifetime major cardiovascular conditions including heart attack or heart failure
  • Current substance use disorder
  • Current major psychiatric disorders like major depressive disorder or bipolar disorder
  • Current vision or hearing impairment that interferes with testing
  • Any electronic or metallic implants in the skull or brain
  • Current medication use known to alter HD-tDCS reactivity

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 6 weeks total including 3 HD-tDCS conditions separated by 14 days washout periods

Participants complete baseline memory and cognitive assessments and undergo three consecutive daily sessions of high definition transcranial direct current stimulation (HD-tDCS) under one of three conditions (sham, active frontal, active temporal), which are counterbalanced across three separate periods separated by 14 days.

10 visits (in-person) including baseline, three consecutive daily stimulation sessions per condition, and post-stimulation assessments for each of the three conditions

Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

H

Hannah Cabrera, MCRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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