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Early Neuromodulation in Traumatic Brain Injury

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Cincinnati
NCT06871124 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The two goals of the proposed study are: (1) To determine how brain activity changes with cognitive recovery over time from acute to chronic phases of traumatic brain injury (TBI). (2) To determine how the time of anodal transcranial electrical stimulation (A-tES) administration affects cognitive performance and brain activity in TBI. To achieve these study goals, the investigators will conduct a pilot clinical trial over three years in which the investigators aim to recruit 60 patients with moderate to severe TBI at the University of Cincinnati Medical Center (UCMC). During the acute phase of TBI, all participants will complete clinical questionnaires and perform 2 cognitive computer tasks while their brain activity is recorded. Half of the participants will be randomly selected to receive A-tES for 15 minutes while performing cognitive tasks and the other half will receive sham stimul

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Moderate to severe TBI: Glasgow Coma Scale (GSC) in the 3-12 range and greater than 30 min of loss of consciousness and/or a post-traumatic amnesia that lasts more than 24 hours and/or an alteration of mental state over 24 hours, 2. age 18-80 years, 3. Isolated TBI, 4. Intelligible speech and Galveston Orientation and Amnesia Test (GOAT) score \>70 at time of enrollment. Exclusion Criteria: 1. Persistent bilateral non-reactive pupils or other evidence of non-survivable injury, 2. Decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) Co-enrollment in another therapeutic TBI trial, (4) Pregnancy, (5) Patients with polytrauma (6) Patients with clinical seizures or status epilepticus.
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What it tests

  • transcranial electrical stimulation
  • Sham Comparator
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Where

1 site
University of Cincinnati
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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