Actively Recruiting
Early Neuromodulation for Cognitive Recovery and Rehabilitation in Traumatic Brain Injury
Led by University of Cincinnati · Updated on 2026-06-03
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how brain activity changes as people recover cognitively after moderate to severe traumatic brain injury (TBI). This study also investigates how the timing of anodal transcranial electrical stimulation (A-tES) affects thinking skills and brain activity. The goal is to find brain patterns linked to cognitive recovery and to see whether early electrical stimulation improves cognitive function compared to stimulation given later during recovery. Participants will be randomly assigned to receive either real A-tES or sham (placebo) stimulation within 1 to 2 weeks after injury. All participants will perform cognitive tasks while their brain activity is recorded using EEG. They will return for follow-up visits at 3 months—when all receive active A-tES during tasks—and at 6 months, when cognitive tests and brain recordings are done without stimulation. The study lasts 6 months and tracks cognitive performance and quality of life. Throughout the study, participants complete questionnaires, cognitive computer tasks, and EEG monitoring at each visit. Researchers measure changes in brain rhythms and task performance from enrollment through 6 months after injury. The study also compares how early versus later A-tES affects recovery. Safety and cognitive improvements are monitored during the 6-month follow-up period, helping to understand the best timing for brain stimulation therapy after TBI.
CONDITIONS
Brief Title
Early Neuromodulation in Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe traumatic brain injury (Glasgow Coma Scale 3-12, loss of consciousness >30 minutes, or post-traumatic amnesia >24 hours, or altered mental state >24 hours)
- Age between 18 and 80 years
- Isolated traumatic brain injury without other major injuries
- Intelligible speech and Galveston Orientation and Amnesia Test (GOAT) score above 70 at enrollment
You will not qualify if you...
- Persistent bilateral non-reactive pupils or non-survivable injury
- Decompressive craniectomy to treat refractory intracranial pressure after diffuse injury
- Participation in another therapeutic traumatic brain injury trial
- Pregnancy
- Patients with multiple injuries (polytrauma)
- Clinical seizures or status epilepticus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to 3 months after injury
Participants receive anodal transcranial electrical stimulation (A-tES) or sham stimulation during cognitive tasks within 1 to 2 weeks post-injury and again at the 3-month follow-up visit to enhance cognitive recovery.
2 visits (in-person) including initial treatment and 3-month follow-up
Duration - From 3 to 6 months after injury
Participants complete cognitive tasks, EEG recordings, and quality of life questionnaires without stimulation to monitor cognitive recovery and brain function.
1 visit (in-person) at 6 months post-injury
Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
I
Ishita Basu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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