NCT05446584PHASE2Recruiting

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

University of Texas Southwestern Medical Center

Start Date

4/20/2023

Completion Date

5/31/2027

Summary

This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.

Detailed Description

Ten study visits will be completed by each participant. The initial visit will include a blood draw and a baseline memory evaluation. Afterwards, participants will be randomized to begin with one of 3 conditions of HD-tDCS. The three conditions are sham-control, active stimulation to frontal region, and active stimulation to left temporal region. All participants will be expected to completed each HD-tDCS condition, which will be counterbalanced and separated by 14 days. Active HD-tDCS will be applied at 2 mA for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. All subjects will complete memory assessments again immediately following each HD-tDCS condition for a total of four test sessions.

Eligibility Criteria

Age Range: 55 years to No maximum

Inclusion Criteria: 1. Active diagnosis of amnestic mild cognitive impairment 2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample 3. Female and male subjects 4. All races/ethnicities 5. Age 55 years and older 6. Fluent in English Exclusion Criteria: 1. Mild traumatic brain injury within past year 2. Lifetime history of moderate or severe brain injury 3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor) 4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure) 5. Current substance use disorder 6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder) 7. Current vision or hearing impairment that interferes with testing 8. Any electronic and or metallic implants in the skull or brain 9. Current medication use known to alter HD-tDCS reactivity

Interventions

DEVICE

High Definition Transcranial Direct Current Stimulation

Interested in This Trial?

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Conditions

Mild Cognitive ImpairmentAmnestic Mild Cognitive DisorderAmnestic Mild Cognitive ImpairmentMild Traumatic Brain InjuryConcussion, Brain

Locations

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States