Brain Stimulation + Cognitive Training for TBI

(ReSTART Trial)

Overseen By Laura Hemmy, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Minneapolis Veterans Affairs Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for older adults who have experienced a traumatic brain injury (TBI) and are noticing changes in their thinking skills. Participants should be able to complete training at home and attend assessments before and after the program.

Inclusion Criteria

Self-reported or medically documented attention and/or concentration difficulties

I am a veteran aged 65 or older.

Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator

Exclusion Criteria

I do not have any health conditions that could risk my safety or affect the study's results.

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

Moderate to severe cognitive impairment with MoCA score less than 15

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview

The study is testing if brain stimulation (tDCS) alongside cognitive training improves attention, memory, and decision-making in seniors with TBI. One group gets real tDCS; the other gets sham tDCS during computer-based exercises.

How Is the Trial Designed?

Group I: Active tDCS with cognitive training Experimental Treatment 1 Intervention

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).

Group II: Sham tDCS with cognitive training Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+