Actively Recruiting
Early Neuromodulation in Traumatic Brain Injury
Led by University of Cincinnati · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 stimulation. All participants will be followed for 6 months. During their 3-month follow-up, the investigators will perform another session where all participants complete the questionnaires and receive A-tES while performing cognitive tasks during brain recording. In their last visit at 6 months post-injury, all participants will complete the questionnaires and cognitive tasks with brain recording but no stimulation treatment. From the collected data, the investigators will determine if time from brain injury correlates with brain activity during performance of cognitive tasks. The investigators will also assess the efficacy of early A-tES treatment for improving cognitive task performance and clinical test ratings at 6 months post-injury in comparison to A-tES delivered during the 3-month follow-up visit.
CONDITIONS
Official Title
Early Neuromodulation in Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe traumatic brain injury defined by Glasgow Coma Scale score between 3 and 12, with more than 30 minutes loss of consciousness and/or post-traumatic amnesia lasting over 24 hours and/or altered mental state lasting more than 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 greater than 70 at enrollment
You will not qualify if you...
- Persistent bilateral non-reactive pupils or evidence of non-survivable injury
- Decompressive craniectomy for refractory intracranial pressure after diffuse injury
- Participation in another therapeutic traumatic brain injury trial
- Pregnancy
- Presence of multiple trauma (polytrauma)
- Clinical seizures or status epilepticus
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
I
Ishita Basu, PhD
CONTACT
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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