Recruiting
Phase 2

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05446584

Conditions

Mild Cognitive Impairment

Amnestic Mild Cognitive Disorder

Amnestic Mild Cognitive Impairment

Mild Traumatic Brain Injury

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

High Definition Transcranial Direct Current Stimulation

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment

Amnestic Mild Cognitive Disorder

Amnestic Mild Cognitive Impairment

Mild Traumatic Brain Injury

Concussion, Brain

Study ID

NCT05446584

Start date

Apr 20, 2023

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Active left frontal HD-tDCS

Electrodes will be placed in a 4x1 ring configuration over the frontal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

active comparator: Active left temporal HD-tDCS

Electrodes will be placed in a 4x1 ring configuration over the left temporal region in accordance with the International 10-10 EEG system. Stimulation will consist of a ramp up period in which the electrical current is gradually increased, 30 minutes of stimulation at 2 mA, and a ramp down period during which the electrical current is gradually removed. Stimulation will be applied back-to-back over three consecutive days.

sham comparator: Sham HD=tDCS

Electrodes will be placed in the same 4x1 ring configuration over the frontal region as the active left frontal condition to ensure a useful control condition. Stimulation will consist of a 30-second ramp up period until reaching 2 mA, followed immediately by a 30-second ramp down, and off for 29 minutes. The same ramp up and down process will be repeated in the final minute of the session to help preserve masking of conditions. Sham stimulation will be applied back-to-back over three consecutive days.

Interventions

High Definition Transcranial Direct Current Stimulation

HD-tDCS for this study is not intended to be a treatment, and will be applied continuously for 30 minutes at sham (0 mA) or 2 mA for active conditions across 3 consecutive daily sessions to probe neural circuit integrity. This specific HD-tDCS device is completely computer driven, running on a laptop using specialized software. Circular electrodes (12-mm in diameter) filled with conductive gel will be placed in a 4x1 ring configuration with the central electrode being the anode surrounded by four cathodes.

Primary outcome measure

  • Changes in Rey Auditory Verbal Learning Test Score [ Time Frame: Baseline and immediately after completion of each HD-tDCS condition ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • MCI
  • TBI
  • memory
  • biomarker
  • Alzheimer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-20.