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NCT06871124
Early Neuromodulation in Traumatic Brain Injury
Conditions: Traumatic Brain Injury (TBI) Patients
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University of Cincinnati
Location: University of Cincinnati Cincinnati Ohio
Summary
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.
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.
Source: ClinicalTrials.gov (NCT06871124). StuddyBuddy aggregates publicly available trial information.
