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

Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI (Cognetric)

This study is testing a new way to help Active Duty Service Members and Veterans with mild traumatic brain injury improve their attention by combining brain stimulation with cognitive training.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: United States Naval Medical Center, San Diego (Federal)
• Locations: 2 sites (San Diego, California and 1 other locations)
• Trial ID: NCT06413173 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include Active Duty Service Members and Veterans aged 18 to 60 with a history of mild TBI and self-reported attention difficulties.

Not a fit: Patients with significant medical or psychiatric conditions that could interfere with study participation or data integrity may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance cognitive rehabilitation for patients with mTBI, leading to improved attention and overall quality of life.

How similar studies have performed: Other studies have shown promise with similar neuroplasticity-based interventions, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

San Diego, California and 1 other locations

• 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

Conditions Brain Concussion; Brain Trauma; Attention Concentration Difficulty; Brain Injuries; Brain Injuries, Traumatic; Neurocognitive Dysfunction; Attention Impaired; Memory Impairment