Tiny study probes how seizure meds affect brain wiring after injury

NCT ID NCT06081283

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study aimed to see if antiseizure drugs like phenobarbital and levetiracetam change brain connectivity patterns in people with severe acute brain injury and reduced consciousness. Only 5 participants were enrolled before the study was terminated. Researchers used resting-state fMRI to compare brain networks before and after treatment. The study was too small to draw firm conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Phenobarbital and levetiracetam (antiseizure medications)
What this could lead to: If successful, this could help doctors understand how antiseizure drugs affect brain networks after injury, potentially guiding better treatment for patients with suppressed consciousness.
What could go wrong: This was a very small pilot study (only 5 participants) that was terminated early, so results are limited and may not apply to larger populations. The study was exploratory, not designed to prove effectiveness.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

5 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 months to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia Brain Injuries, Traumatic brain injury brain ischemia cardiac arrest Coma Hypoxia, Brain intracerebral hemorrhage Intracranial Hemorrhages ocular motor apraxia, Cogan type perinatal asphyxia Persistent Vegetative State stroke disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain hypoxia Brain injuries, acute Brain injuries, traumatic Brain ischemia COMA Heart arrest Hypoxia-ischemia, brain Intracranial hemorrhages Persistent vegetative state Stroke

Tiny study probes how seizure meds affect brain wiring after injury

What the study statuses mean