Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

Part of paid clinical trials in Dallas, Texas.

Sponsor
The University of Texas at Dallas
Study ID
NCT04869059
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial direct current stimulation — DEVICE
    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
  • sham tDCS — DEVICE
    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Study Details

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military veteran participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Key Dates

Start date
Aug 1, 2021
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcranial direct current stimulation
    20 minutes of 1 milliamp transcranial direct current stimulation to presupplementary motor area for 15 sessions
  • Sham Comparator: Sham transcranial direct current stimulation
    20 minutes of sham transcranial direct current stimulation to presupplementary motor area for 15 sessions

Primary Outcome Measure

Treatment group differences in change from Baseline to 3-months Post-Treatment on the Controlled Oral Word Association Test [ Time Frame: Outcome measures will be assessed as change over a period of 17 weeks: Change from baseline to 3-month Post-Treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas at DallasDallasTexas75235
Ashna Adhikari
[email protected]
972-883-3161
Tyler Vintila
[email protected]
972-883-3161
Michael Motes, PhD (SUB_INVESTIGATOR)

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