Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

NCT05446584 | Recruiting Phase 2 DMC

• 1 other identifier: STU-2022-0591
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

MCI; TBI; memory; biomarker; Alzheimer

Outcome Measures

Primary Outcomes (1)

• Changes in Rey Auditory Verbal Learning Test Score

  The RAVLT is a verbal episodic memory test that is sensitive to mesial and lateral verbal episodic memory circuit dysfunction. The primary outcome measure for this task is the total number of items immediately recalled during the learning trials and after the 20 minute delayed recall trial. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.

  Baseline and immediately after completion of each HD-tDCS condition

Secondary Outcomes (2)

• Changes in Delis Kaplan Executive Function System (DKEFS) Trail Making Test

  Baseline and immediately after completion of each HD-tDCS condition

• Changes in Delis Kaplan Executive Function System (DKEFS) Color-Word Interference Test

  Baseline and immediately after completion of each HD-tDCS condition

Study Arms (3)

Active left frontal HD-tDCS

ACTIVE COMPARATOR

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.

Device: High Definition Transcranial Direct Current Stimulation

Active left temporal HD-tDCS

ACTIVE COMPARATOR

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.

Device: High Definition Transcranial Direct Current Stimulation

Sham HD=tDCS

SHAM COMPARATOR

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.

Device: High Definition Transcranial Direct Current Stimulation

Interventions

High Definition Transcranial Direct Current Stimulation DEVICE

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.

Active left frontal HD-tDCS; Active left temporal HD-tDCS; Sham HD=tDCS

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active diagnosis of amnestic mild cognitive impairment
• Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample
• Female and male subjects
• All races/ethnicities
• Age 55 years and older
• Fluent in English

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Concussion

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Hannah Cabrera, MCRC

CONTACT

214-865-9508; Hannah.Cabrera@utsw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All subjects will complete 3 conditions of HD-tDCS. Each HD-tDCS condition is comprised of 3 days of active or sham stimulation targeting the left frontal and temporal lobes (i.e., within-subjects design), randomized by order, and separated by 14 days to avoid carry-over effects.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: April 20, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)