Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Stopped early · Phase 4

Conditions studied: Brain Injuries, Acute, Brain Injuries, Traumatic, Brain Ischemia, Brain Hypoxia, Hypoxia-Ischemia, Brain, Heart Arrest, Stroke, Intracranial Hemorrhages, Coma, Persistent Vegetative State

In brief

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.

Key facts

Study ID

NCT06081283

Run by

University of North Carolina, Chapel Hill

People needed

5

Starts

2023-11-20

Expected to finish

2025-01-22

Last updated by the study team

2025-11-14

Who can join

Age: 2 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UNC Health — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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