Early Neuromodulation in Traumatic Brain Injury

Launched by UNIVERSITY OF CINCINNATI · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Early Neuromodulation in Traumatic Brain Injury," is studying how brain activity changes as patients recover from a traumatic brain injury (TBI) over time. The researchers want to find out if a specific treatment called anodal transcranial electrical stimulation (A-tES) can help improve thinking and memory skills in TBI patients. They will recruit 60 patients aged 18 to 80 who have moderate to severe TBIs. To be eligible, patients must have experienced significant loss of consciousness and show some level of impaired mental state after their injury.

During the trial, participants will complete questionnaires and cognitive tasks to assess their brain activity. Some will receive the A-tES treatment while working on these tasks, while others will have a similar experience without the actual treatment, known as sham stimulation. The study will follow participants for six months, with assessments at three different points in time. This research aims to help understand when and how treatments can be most effective for improving cognitive recovery in TBI patients.

Gender

ALL

Eligibility criteria

• 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.