Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

Launched by UNITED STATES NAVAL MEDICAL CENTER, SAN DIEGO · May 9, 2024

Keywords

ClinConnect Summary

The Cognetric clinical trial is investigating a new way to help people with mild traumatic brain injury (mTBI) improve their attention and concentration. This method combines a brain stimulation technique called Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS+) with cognitive training exercises. The goal is to see if this approach can enhance brain function in Active Duty Service Members and Veterans who have experienced mTBI. Participants will engage in tests and questionnaires to assess their attention and any related symptoms, and researchers will also look at how the brain's electrical activity changes during the treatment.

To be eligible for this study, participants should be Active Duty Service Members aged 18 to 60 with a history of mild TBI that occurred at least three months but no more than ten years ago. They should also report difficulties with attention or concentration. Throughout the trial, participants can expect to receive either the active treatment or a placebo (a fake version of the treatment), and their progress will be monitored over a few weeks after the treatment ends. This study aims to understand not only the effectiveness of the treatment but also how individual factors, like PTSD or sleep quality, might influence outcomes.

Gender

ALL

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.