Remote Stimulation and Training to Advance Recovery From TBI in Seniors

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Minneapolis Veterans Affairs Medical Center
Study ID
NCT07332299
Status
Recruiting

Conditions

  • Aging Related Cognitive Decline
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active tDCS and Cognitive Training Intervention — COMBINATION_PRODUCT
    Forty-five minutes of cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for the first 20 minutes of the session.
  • Sham tDCS and Cognitive Training Intervention — COMBINATION_PRODUCT
    Forty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active tDCS with cognitive training
    Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (45 minutes of cognitive training with tDCS applied for first 20 minutes of session; tDCS: 2mA, 30s ramp up/down, anode at F3, cathode at F4).
  • Sham Comparator: Sham tDCS with cognitive training
    Participants will receive 10 sessions of cognitive training concurrent with sham transcranial direct current stimulation (45 minutes of cognitive training with sham tDCS: 2mA current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning, anode at F3, cathode at F4).

Primary Outcome Measure

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis VA Health Care SystemMinneapolisMinnesota55417
Casey S Gilmore, PhD
612-629-7466
Laura Hemmy, PhD
612-467-2323
Casey S Gilmore, PhD (PRINCIPAL_INVESTIGATOR)

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