tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

Summary

The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.

Conditions

• Brain Concussion
• Brain Trauma
• Attention Concentration Difficulty
• Brain Injuries
• Brain Injuries, Traumatic
• Neurocognitive Dysfunction
• Attention Impaired
• Memory Impairment
• Mild Traumatic Brain Injury
• Mild Cognitive Impairment

Interventions

COMBINATION_PRODUCT

active tDCS and cognitive training intervention

Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first 13 minutes (shut off: Minute 13) of the session and the last 13 minutes of the session (turn on: Minute 33). The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.

COMBINATION_PRODUCT

sham tDCS and cognitive training intervention

Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first and last 13 minutes of the session. For sham stimulation, the electrodes will be placed at the same positions as for active stimulation, but current will be ramped down immediately after the initial 30s ramp up period. The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center

  collaborator FED

• United States Naval Medical Center, San Diego

  lead FED

Principal Investigators

• Lars D Hungerford, PhD · United States Naval Medical Center, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-19

Primary Completion

2025-06-30

Completion

2025-07-30

Countries

• United States

Study Locations