NCT07332299 Remote Stimulation and Training to Advance Recovery From TBI in Seniors
| NCT ID | NCT07332299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minneapolis Veterans Affairs Medical Center |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-01-15 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07332299 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07332299 currently recruiting?
Yes, NCT07332299 is actively recruiting participants. Contact the research team at casey.gilmore2@va.gov for enrollment information.
Where is the NCT07332299 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07332299 clinical trial?
NCT07332299 is sponsored by Minneapolis Veterans Affairs Medical Center. The trial plans to enroll 40 participants.