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NCT Number: NCT05446584

Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

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.

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Key information

Conditions

Mild Cognitive Impairment Amnestic Mild Cognitive Disorder Amnestic Mild Cognitive Impairment Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Concussion, Brain Craniocerebral Trauma Head Injuries, Closed Mental Disorders Mild Traumatic Brain Injury Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Changes in Rey Auditory Verbal Learning Test Score

    Time frame: Baseline and immediately after completion of each HD-tDCS condition

    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.

Secondary outcomes

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

    Time frame: Baseline and immediately after completion of each HD-tDCS condition

    The DKEFS Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete five conditions, involving number cancellation, number sequencing, letter sequencing, number-letter switching, and line tracing. The outcome measure for this task is the time to complete each of the five conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.

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

    Time frame: Baseline and immediately after completion of each HD-tDCS condition

    The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measure for this task is the time to complete each of the four conditions. Changes in scores from baseline to testing immediately following the completion of each condition will be examined.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Cabrera, MCRC

CONTACT

[email protected]

214-865-9508

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: PATH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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