NCT06413173 Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
| NCT ID | NCT06413173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | United States Naval Medical Center, San Diego |
| Condition | Brain Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-07-25 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Lars D Hungerford, PhD
PRINCIPAL INVESTIGATOR
United States Naval Medical Center, San Diego
Frequently Asked Questions
Who can join the NCT06413173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Brain Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06413173 currently recruiting?
Yes, NCT06413173 is actively recruiting participants. Contact the research team at lars.d.hungerford.ctr@health.mil for enrollment information.
Where is the NCT06413173 trial being conducted?
This trial is being conducted at San Diego, United States, Minneapolis, United States.
Who is sponsoring the NCT06413173 clinical trial?
NCT06413173 is sponsored by United States Naval Medical Center, San Diego. The principal investigator is Lars D Hungerford, PhD at United States Naval Medical Center, San Diego. The trial plans to enroll 160 participants.