Status:
TERMINATED
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Brain Injuries, Acute
Brain Injuries, Traumatic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of con...
Eligibility Criteria
Inclusion
- Currently ICU hospitalized.
- Suppression of consciousness related to a neurological injury by medical chart review.
- Glasgow Coma Scale of less than 13 at enrollment by medical chart review.
- Diagnosis of Acute brain injury by traumatic brain injury (TBI), hypoxic-ischemic insult, cardiac arrest, or stroke by medical chart review.
- 2 to 90 days from acute brain injury to enrollment time by medical chart review.
- Have a surface EEG performed after the current ICU admission
- Clinically stable to undergo MRI scan, This stability is defined by care team concept, which should be stated in the medical records.
Exclusion
- Previous medical history of Epilepsy by medical chart review.
- Previous medical history of neurological sequels that lead to dependence on care for basic daily activities, by Barthel index score less than 80.
- Known allergy/Hypersensitivity or medical contraindications (like porphyria or cardiac arrhythmias) to the treatment protocol options, leaving no potential combination of drugs for the intervention without concerns for adverse events related to known preexistent conditions.
- Considered with Brain death by the care team in the medical record, at any time.
- Speaking fluently or at their prior reported baseline mental status by medical chart review before the intervention starts.
- Contraindications for MRI scan.
- Prisoner human subjects by medical chart review.
- Confirmed currently pregnant by medical history or by positive blood or urine pregnancy test done in the present hospital admission.
- Treating physician determines the patient is no candidate to receive 2 of the 5 protocol-specified ASM.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06081283
Start Date
November 20 2023
End Date
January 22 2025
Last Update
November 14 2025
Active Locations (1)
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1
UNC Health
Chapel Hill, North Carolina, United States, 27599