Not Yet RecruitingPhase 2

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

United States46 participantsStarted 2027-05-24

Plain-language summary

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.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * History of chronic mTBI as measured by Ohio State University Traumatic Brain Injury Identification Method * mTBI occurred \> 5 years prior to study enrollment * History of PTSD with symptoms within the last month as confirmed PTSD Checklist (past month) score greater than or equal to 33, * Cognitive impairment as defined by telephone Montreal Cognitive Assessment \< 19 * No history of reported or documented age-related or neurodegenerative condition * Access to internet for 1 hour per day * Willing and able to comply with all study related procedures and capable of independently reading and understanding study materials and providing informed consent. Exclusion Criteria: * Skin lesions at the stimulation site that may increase conductance * Metallic objects in the face or head (e.g. braces, fillings, implants) * Pregnancy/lactation or planning to become pregnant during study * History of other significant neurological disorders including seizure disorder, central nervous system tumors, stroke, cerebral aneurysm * History of primary psychotic disorder, bipolar I disorder, active substance use disorder (moderate or greater, measured by Drug Abuse Screening Test-10) * Active suicidal intent or plan, measured by Columbia-Suicide Severity Rating Scale * Other conditions or circumstances that, in the opinion of investigator team, have the potential to prevent completion and/or have a confounding effect on outcome assessments. * Unable to tolerate 2mA transc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial using remotely administered tDCS — a form of brain stimulation done at home — to help with thinking and memory problems in Veterans with both mild traumatic brain injury and PTSD; given that it's still in Phase 2, what do we know so far about whether this approach is safe and how much benefit is realistic to expect?
2The trial measures improvement using something called the NIH Toolbox Fluid Composite score, which tracks things like memory, attention, and processing speed — based on my specific cognitive symptoms, does my doctor think those are the areas where I'd most likely notice a meaningful change?
3Since the trial isn't recruiting yet, how long might it realistically be before I could actually enroll, and are there other treatments or therapies I should be pursuing in the meantime for my cognitive symptoms?
4Because the tDCS sessions are delivered remotely, meaning I'd be doing the brain stimulation at home rather than in a clinic, what kind of technical setup or supervision would be involved, and is that something my living situation could realistically support?
5Are there existing standard-of-care treatments for cognitive difficulties related to mTBI or PTSD that my doctor would recommend I try first, or would participating in this trial be a reasonable path to consider alongside or instead of those options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIH Toolbox Fluid Composite score

Timeframe: Pre- and post-intervention (immediate and 2 months)

Trial details

NCT IDNCT07414537

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2029-11-26

Contact for this trial

Kelly L Sloane, PhD

(215) 823-5800 kelly.sloane@va.gov

View on ClinicalTrials.gov More Cognition trials