Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05446584
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amnestic Mild Cognitive Disorder
  • Amnestic Mild Cognitive Impairment
  • Concussion, Brain
  • Mild Cognitive Impairment
  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Christian B LoBue, PhD
[email protected]
Hannah Cabrera, MS
[email protected]
214-865-9508

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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