Recruiting

tDCS & Cognitive Training

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT07332299

Conditions

Traumatic Brain Injury

Aging Related Cognitive Decline

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Active tDCS and Cognitive Training Intervention

Sham tDCS and Cognitive Training Intervention

Study Details

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.

Conditions

Traumatic Brain Injury

Aging Related Cognitive Decline

Study ID

NCT07332299

Start date

Jan 15, 2026

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Active tDCS and Cognitive Training Intervention

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

Forty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).

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 ]
  • Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]

Central Contacts and Locations

Central contacts

Locations

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Principal Investigator:

Casey S Gilmore, PhD

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • Aging
  • Cognitive Training
  • Transcranial Direct Current Stimulation
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2026-01-12.