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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 19, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

August 30, 2025

Conditions
Brain ConcussionBrain TraumaAttention Concentration DifficultyBrain InjuriesBrain Injuries, TraumaticNeurocognitive DysfunctionAttention ImpairedMemory ImpairmentMild Traumatic Brain InjuryMild 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.

Trial Locations (1)

92134

RECRUITING

Naval Medical Center San Diego, San Diego

All Listed Sponsors
collaborator

The Defense and Veterans Brain Injury Center

FED

lead

United States Naval Medical Center, San Diego

FED