Remote brain stimulation and cognitive training to improve thinking after TBI in seniors
Remote Stimulation and Training to Advance Recovery From TBI in Seniors
This test will see if combining at-home transcranial direct current stimulation (tDCS) with computer-based cognitive training improves attention, memory, and decision-making in veterans aged 65 and older who had a mild TBI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Minneapolis Veterans Affairs Medical Center Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07332299 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 65 or older with a history of mild TBI at least three months prior, who report attention or concentration difficulties, are on stable medication regimens, and can provide informed consent and participate in remote training.
Not a fit: Patients with more severe or unstable medical, psychiatric, or neurological conditions, those unable to complete home-based computer exercises or attend VA visits, non-veterans, or people under 65 are unlikely to match this study's population or benefit.
Why it matters
Potential benefit: If successful, the combined home-based program could improve cognitive abilities and everyday functioning, helping older adults with TBI maintain greater independence.
How similar studies have performed: Previous small studies of tDCS plus cognitive training have shown mixed but sometimes promising short-term cognitive gains, while larger confirmatory trials and fully remote programs remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.