Using brain stimulation to improve cognitive recovery in traumatic brain injury
Early Neuromodulation for Cognitive Recovery and Rehabilitation in Traumatic Brain Injury
This study is testing if a type of brain stimulation can help improve thinking skills in people with moderate to severe traumatic brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06871124 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how brain activity changes during cognitive recovery in patients with moderate to severe traumatic brain injury (TBI). It will assess the effects of anodal transcranial electrical stimulation (A-tES) on cognitive performance and brain activity during the acute phase of TBI. A total of 60 participants will be recruited, with half receiving A-tES while performing cognitive tasks and the other half receiving sham stimulation. Participants will be monitored for six months to evaluate changes in cognitive function and brain activity over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with moderate to severe TBI as defined by specific clinical criteria.
Not a fit: Patients with non-survivable injuries, polytrauma, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cognitive recovery and rehabilitation strategies for TBI patients.
How similar studies have performed: While some studies have explored brain stimulation for cognitive recovery, this approach focusing on the acute phase of TBI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Ishita Basu, PhD
- Email: basuia@ucmail.uc.edu
- Phone: 5135583991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.