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RECRUITING

NCT06413173

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

Sponsor: United States Naval Medical Center, San Diego

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-07-25

Completion Date

2028-09-30

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Brain Concussion Brain Trauma Attention Concentration Difficulty Brain Injuries Brain Injuries, Traumatic Neurocognitive Dysfunction Attention Impaired Memory Impairment Mild Traumatic Brain Injury Mild Cognitive Impairment Post Concussive Symptoms

Interventions

COMBINATION_PRODUCT

Active tDCS and Cognitive Training Intervention

Cognitive training will occur concurrently with active tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.

COMBINATION_PRODUCT

Sham tDCS and Cognitive Training Intervention

Cognitive training will occur concurrently with sham tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.

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.

Locations (2)

Naval Medical Center San Diego

San Diego, California, United States

Minneapolis VA Health Case System

Minneapolis, Minnesota, United States