Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD Principal Investigator

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT07414537
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Brain Injuries
  • Cognition
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

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

Interventions

  • Transcranial direct current stimulation (tDCS) — DEVICE
    Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Participants will be randomized to active tDCS or sham tDCS for 20 minutes per day for 10 consecutive weekdays.
  • Cognitive training — OTHER
    Participants in both arms will undergo cognitive training while tDCS (Active or Sham) is being administered. Cognitive exercises will be completed through the mobile application BrainHQ.

Study Details

Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. There are few effective interventions to improve cognition in Veterans with cognitive impairment due to these conditions. Non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS), can be used to stimulate activity in areas of the brain to optimize recovery and rehabilitation. In this study, the investigators are conducting a randomized controlled trial of tDCS to improve cognitive function in Veterans with cognitive impairment due to co-morbid TBI and PTSD. TDCS is remotely administered and paired with cognitive training.

Key Dates

Start date
May 24, 2027
Status verified
Feb 2026
Primary completion
Nov 26, 2029
Completion
Nov 30, 2030

Study Design

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

Arms

  • Active Comparator: tDCS
    Active transcranial direct current stimulation (tDCS)
  • Sham Comparator: Sham tDCS
    Sham transcranial direct current stimulation (tDCS)

Primary Outcome Measure

NIH Toolbox Fluid Composite score [ Time Frame: Pre- and post-intervention (immediate and 2 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
Kelly L Sloane, PhD
215-823-5800
Kelly L Sloane, PhD (PRINCIPAL_INVESTIGATOR)

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