Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Last updated: February 11, 2025
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Not Recruiting

Phase

4

Condition

Stroke

Cerebral Ischemia

Hemorrhage

Treatment

Phenobarbital Sodium Injection

Levetiracetam

Valproate Sodium

Clinical Study ID

NCT06081283
23-0157
  • Ages 18-70
  • All Genders

Study 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 consciousness. The main questions it aims to answer are:

  • Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population?

  • What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity?

Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Currently ICU hospitalized.

  • Suppression of consciousness related to a neurological injury by medical chartreview.

  • Glasgow Coma Scale of less than 13 at enrollment by medical chart review.

  • Diagnosis of Acute brain injury by TBI, hypoxic-ischemic insult, cardiac arrest, orstroke 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 teamconcept, which should be stated in the medical records.

Exclusion

Exclusion Criteria:

  • Previous medical history of Epilepsy by medical chart review.

  • Previous medical history of neurological sequels that lead to dependence on care forbasic daily activities, by Barthel index score less than 80.

  • Known allergy/Hypersensitivity or medical contraindications (like porphyria orcardiac arrhythmias) to the treatment protocol options, leaving no potentialcombination of drugs for the intervention without concerns for adverse eventsrelated 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 chartreview 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 urinepregnancy test done in the present hospital admission.

  • Treating physician determines the patient is no candidate to receive 2 of the 5protocol-specified ASM.

Study Design

Total Participants: 54
Treatment Group(s): 5
Primary Treatment: Phenobarbital Sodium Injection
Phase: 4
Study Start date:
November 20, 2023
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • UNC Health

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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