Improving attention in military personnel with mild traumatic brain injury using brain stimulation and cognitive training

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a novel approach to cognitive rehabilitation for mild traumatic brain injury (mTBI) by combining remotely supervised transcranial direct current stimulation (RS-tDCS+) with cognitive training. It aims to enhance complex attention in Active Duty Service Members and Veterans who have experienced mTBI. Participants will be randomly assigned to receive either active or sham stimulation, with assessments including symptom questionnaires and brain imaging techniques like EEG and MRI to measure outcomes. The goal is to improve cognitive functioning and quality of life while increasing accessibility to care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Active-Duty Service Members.
2. Ages 18 to 60.
3. All genders.
4. All racial and ethnic groups.
5. History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.
6. Self-reported attention and/or concentration difficulties.
7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.

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 PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of 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, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.
2. History of prior treatment with ECT or neuromodulation in the last 12 months.
3. Current, diagnosed substance dependence.
4. Newly prescribed medication within the previous 3 weeks.
5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).
6. Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk.
7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
8. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
9. A positive pregnancy report.

Where it's running

• Naval Medical Center San Diego
  San Diego, California, United States Recruiting
• Minneapolis VA Health Case System
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Lars D Hungerford, PhD — United States Naval Medical Center, San Diego
• Study coordinator: Lars D Hungerford, PhD
• Email: lars.d.hungerford.ctr@health.mil
• Phone: 619.532.5715

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.