Remote brain stimulation and cognitive training to improve thinking after TBI in seniors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional program assigns older veterans with prior mild TBI to receive either active tDCS during computerized cognitive training or sham tDCS with the same training, delivered at home with remote supervision. Participants complete adaptive BrainHQ exercises targeting attention, working memory, and decision-making while wearing a tDCS device during training sessions. Investigators collect baseline and post-program cognitive and functional assessments to measure changes in thinking and everyday functioning. The study also measures feasibility and acceptability of a home-based, remotely supervised protocol for older adults with TBI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Veterans age 65 and older.
2. History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months prior to enrollment.
3. Self-reported or medically documented attention and/or concentration difficulties.
4. Stable dose of all prescription and non-prescription medications that may impact cognition or brain chemistry (except for PRN medication) for at least 3 weeks prior to the baseline session (Visit 1), in the medical opinion of the principal investigator.
5. Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator.

Exclusion Criteria:

1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the principal investigator: (a) may pose a significant risk to the participant, (b) raises the possibility that the participant is unlikely to successfully complete all the requirements of the study according to the study protocol, or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of brain tumor near the stimulation site, brain surgery, stroke with current sequalae, epilepsy, multiple sclerosis, Huntington's Disease, ALS, ataxia, aphasia, Alzheimer's Disease, and dementia.
2. Moderate to severe cognitive impairment with MoCA score (assessed upon enrollment) less than 15.
3. Prior treatment with ECT or neuromodulation in the last 12 months.
4. Current severe alcohol or substance use disorder with evidence of withdrawal or tolerance within the past 6 months, based on psychiatric history and/or a review of available medical records.
5. Psychosis or mania within 30 days of enrollment, as determined by the principal investigator, based on psychiatric history and/or a review of available medical records.
6. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp near electrode site, etc.).
7. No or limited internet connection in their home.

Where it's running

• Minneapolis VA Health Care System
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Casey S Gilmore, PhD
• Email: casey.gilmore2@va.gov
• Phone: 612-629-7466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.