Actively Recruiting
Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
Led by United States Naval Medical Center, San Diego · Updated on 2025-11-12
160
Participants Needed
2
Research Sites
218 weeks
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
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.
CONDITIONS
Official 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 TBI 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 affect study completion or data validity
- History of brain tumor, epilepsy, stroke, schizophrenia, bipolar disorder, or mania
- Prior treatment with ECT or neuromodulation in the last 12 months
- Current diagnosed substance dependence
- Newly prescribed medication within the previous 3 weeks
- Intellectual disability or pervasive developmental disorder with IQ ≤70
- Significant neurological disorders other than mild TBI
- Psychosis or mania within 30 days prior to enrollment
- Contraindications for tDCS such as metallic cranial implants or scalp skin lesions
- Positive pregnancy test
AI-Screening
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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
CONTACT
S
Sean M Molnar, M.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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