Actively Recruiting
Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild Traumatic Brain Injury
Led by United States Naval Medical Center, San Diego · Updated on 2025-11-12
160
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
United States Naval Medical Center, San Diego
Lead Sponsor
M
Minneapolis Veterans Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new way to help improve complex attention in Active Duty Service Members and Veterans who have experienced mild traumatic brain injury (mTBI). This study tests a home-based, non-invasive brain stimulation method called Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training (RS-tDCS+). The goal is to boost cognitive training effects by enhancing brain learning and reorganization. The study also examines brain changes using EEG and MRI scans and looks at how factors like PTSD, depression, and sleep quality affect outcomes. Participants will be randomly assigned to receive either active RS-tDCS or a sham (placebo) version along with cognitive training exercises. They will complete 10 sessions over two weeks at home, with stimulation applied for 20 minutes per session via electrodes on a special headband. Cognitive training involves five computer-based exercises targeting executive functions such as working memory and decision making, adapted to each participant's ability. After the intervention, participants are assessed again at one week and six weeks to measure lasting effects. During the study, participants will undergo tests of attention and symptoms along with brain imaging at baseline and post-intervention. Daily assessments of symptoms, cognition, and mood will be collected during and after treatment through momentary surveys. Researchers will monitor safety through symptom questionnaires and track quality of life changes. The entire participation lasts several weeks, including treatment and follow-up assessments to evaluate both immediate and lasting impacts of the intervention.
CONDITIONS
Brief Title
Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active-Duty Service Members
- Ages 18 to 60
- All genders
- All racial and ethnic groups
- History of mild traumatic brain injury sustained at least 3 months and no more than 10 years prior
- Self-reported attention and/or concentration difficulties
- At least one cognitive symptom on the Neurobehavioral Symptom Inventory cognitive subscale
You will not qualify if you...
- Medical, psychiatric, physical or other conditions that pose significant risk or prevent study completion as judged by the principal investigator
- History of brain tumor, epilepsy, stroke, schizophrenia, bipolar disorder, or mania
- Prior electroconvulsive therapy or neuromodulation treatment within 12 months
- Current diagnosed substance dependence
- Newly prescribed medication within 3 weeks
- Intellectual disability or pervasive developmental disorder with IQ less than or equal to 70
- Medical conditions other than mild TBI impacting neurological risk
- Psychosis or mania within 30 days of enrollment
- Contraindications for tDCS such as metallic cranial implants or scalp skin conditions
- Positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive 10 sessions of cognitive training combined with transcranial direct current stimulation (tDCS) at home. Each session includes 45 minutes of cognitive training with 20 minutes of tDCS at the beginning, supervised remotely.
10 sessions at home over 2 weeks
Duration - 6 weeks
Participants undergo two post-intervention assessments approximately 1 week and 6 weeks after treatment to evaluate cognitive function, symptoms, and quality of life. Daily symptom and mood data are collected remotely during the 6 weeks after treatment.
2 in-person assessment visits and daily remote assessments for 6 weeks
Trial Site Locations
Total: 2 locations
1
Naval Medical Center San Diego
San Diego, California, United States, 92134
Actively Recruiting
2
Minneapolis VA Health Case System
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
Research Team
L
Lars D Hungerford, PhD
S
Sean M Molnar, M.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here