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

Study acronym: COGNETRIC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 2 of 2 sitesv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2024 to Jul 25, 2024
    • Site details revised at 2 of 2 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06413173
Lead Sponsor United States Naval Medical Center, San Diego
Collaborators: Minneapolis Veterans Affairs Medical Center, University of Minnesota, United States Department of Defense, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center, General Dynamics Information Technology
Conditions
(from sponsor)		 Brain Concussion, Brain Trauma, Attention Concentration Difficulty, Brain Injuries, Brain Injuries, Traumatic, Neurocognitive Dysfunction, Attention Impaired, Memory Impairment +3 more
Related terms Brain Concussion, Brain Injuries, Brain Injuries, Traumatic, Cognition Disorders, Cognitive Dysfunction, Memory Disorders, Post-Concussion Syndrome
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov