Remote Stimulation and Training to Advance Recovery From TBI in Seniors
ReSTART
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 12, 2026
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 12, 2026
January 1, 2026
1.6 years
September 17, 2025
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
The RBANS is a commonly-used, psychometrically-sound measure of cognitive function across the lifespan. The primary outcome measure is the Total Scale score, which is a standard score (mean 100, SD 15) across five cognitive domains (Immediate/Delayed Memory, Visuospatial, Attention, Language).
Baseline, 1-week post, & 6-weeks post intervention
Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity
Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands. The primary outcome measure will be change in prefrontal-parietal functional connectivity in the theta frequency band.
Baseline, 1-week post, & 6-weeks post intervention
Secondary Outcomes (5)
Neurobehavioral Symptom Inventory (NSI) Total Score
Baseline, 1-week post, & 6-weeks post intervention
Insomnia Severity Index (ISI) Total Score
Baseline, 1-week post, & 6-weeks post intervention
Patient Health Questionnaire-8 (PHQ-8) Total Score
Baseline, 1-week post, & 6-weeks post intervention
Groton Maze Learning Task (GMLT) Completion Time
Baseline, 1-week post, & 6-weeks post intervention
NIH Toolbox Quality of Life Assessment (NeuroQoL)
Baseline, 1-week post, & 6-weeks post intervention
Study Arms (2)
Active tDCS with cognitive training
EXPERIMENTALParticipants 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 tDCS with cognitive training
SHAM COMPARATORParticipants 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).
Interventions
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.
Forty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2025
First Posted
January 12, 2026
Study Start
January 15, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share