About this trial
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
Qualifiers
Active-Duty Service Members.
Ages 18 to 60.
All genders.
All racial and ethnic groups.
Disqualifiers
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.
History of prior treatment with ECT or neuromodulation in the last 12 months.
Current, diagnosed substance dependence.
Newly prescribed medication within the previous 3 weeks.
Trial design
Treatments tested in this trial
- Active tDCS and Cognitive Training Intervention
- Sham tDCS and Cognitive Training Intervention
Treatment groups
Locations
2Sponsors and collaborators
United States Naval Medical Center, San Diego
Lead sponsor
Minneapolis Veterans Affairs Medical Center
Collaborator
University of Minnesota
Collaborator
United States Department of Defense
Collaborator
Center for Veterans Research and Education
Collaborator
The Defense and Veterans Brain Injury Center
Collaborator
General Dynamics Information Technology
Collaborator