Remote Stimulation and Training to Advance Recovery From TBI in Seniors (NCT07332299) | Clinical Trial Compass
RecruitingNot Applicable
Remote Stimulation and Training to Advance Recovery From TBI in Seniors
United States40 participantsStarted 2026-01-15
Plain-language summary
The goal of this clinical trial is to learn if combining brain stimulation with cognitive training can improve thinking skills in older adults who have had a traumatic brain injury (TBI).
The main questions are:
* Does transcranial direct current stimulation (tDCS) make cognitive training more effective for improving attention, memory, and decision-making?
* Is this type of home-based program feasible and acceptable for older adults with TBI?
Researchers will compare two groups: one group will receive active tDCS during cognitive training, and the other group will receive sham (placebo) tDCS during cognitive training.
Participants will:
* Complete computer-based cognitive training exercises (BrainHQ) to practice attention, memory, and decision-making.
* Receive either active or sham tDCS during training sessions.
* Complete assessments before and after the program to measure changes in thinking and daily functioning.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Veterans age 65 and older.
✓. 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.
✓. Self-reported or medically documented attention and/or concentration difficulties.
✓. 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.
✓. Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator.
Exclusion criteria
✕. 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.
What they're measuring
1
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
Timeframe: Baseline, 1-week post, & 6-weeks post intervention
2
Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity
Timeframe: Baseline, 1-week post, & 6-weeks post intervention
Trial details
NCT IDNCT07332299
SponsorMinneapolis Veterans Affairs Medical Center
✕. Moderate to severe cognitive impairment with MoCA score (assessed upon enrollment) less than 15.
✕. Prior treatment with ECT or neuromodulation in the last 12 months.
✕. 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.
✕. 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.
✕. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp near electrode site, etc.).
✕. No or limited internet connection in their home.