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Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

NCT ID: NCT06081283

Last Updated: 2025-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-01-22

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Coma Vegetative state Suppression of consciousness antiseizure medication Brain networks Functional connectivity Unresponsive wakefulness Functional MRI Resting state Brain Injuries, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Subjects will be enrolled irrespective of their electroencephalogram (EEG) results, whether positive(+) or negative(-) for epileptogenic activity. All enrolled subjects will undergo an initial resting-state functional MRI (rsfMRI). The results will categorize the patients based on the presence or absence of seizure networks (SzNET), resulting in 2 groups: SzNET+ and SzNET-. SzNET- participants will not undergo further interventions or tests, while SzNET+ subjects will be assigned to the intervention arm and will receive follow-up rsfMRI and EEG.

The study aims to fill 2 quotas in its intervention arm: Participants who are both SzNET+ and EEG+, and another for those SzNET+ but EEG-. Once either of these quotas is complete, the study will cease screening subjects with EEG results falling into that quota. The subjects discharged from hospital on antiseizure medications for medical reasons will be followed up at 3 months post-discharge to collect exploratory data
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Seizure network Positive subjects

Participants in this group include all SzNET-Positive subjects, whether EEG-Positive or EEG-Negative. Within six days of their rs-fMRI #1 study, they will receive both loading and maintenance doses of two intervention drug regimens from the study list. For participants with a Glasgow Coma Scale (GCS) of 9 to 12, the research team will choose one of the two selected antiseizure medications (ASMs) and omit its loading dose. Maintenance doses should be administered every 12 hours, starting 12 hours after the loading dose, with a maximum of 19 doses allowed.

A second rs-fMRI and EEG will occur after participants have received at least five maintenance doses. Following these assessments, the use of the intervention drugs as part of the research intervention will cease. However, if medically necessary, these drugs can continue as part of regular therapy. Note that repeat EEG and rs-fMRI assessments Must occur no longer than 72 hours after the last dose of the intervention drug regimen.

Group Type EXPERIMENTAL

Phenobarbital Sodium Injection

Intervention Type DRUG

\*This drug can only be selected as part of the intervention for the subgroup of patients with a Glasgow Coma Score of 8 or less.

Loading dose 20 mg/kg intravenous. Max dose 1000mg Maintenance dose 4mg/kg/day. Max dose 300mg/day. Adult population Loading dose 20 mg/kg intravenous. Maintenance dose 4mg/kg/day.

Levetiracetam

Intervention Type DRUG

Pediatric population Loading dose 60 mg/kg intravenous. Max dose 4000mg. Maintenance dose 40mg/Kg/day, Max dose 3000mg/day. Adult population Loading dose 2000mg-4000mg intravenous. Maintenance dose 1500mg to 3000mg/day.

Lacosamide Injectable Product

Intervention Type DRUG

Pediatric population Loading dose 10 mg/kg intravenous, Max dose 400mg. Maintenance dose 4mg to 8mg/Kg/day. Max dose 300mg. Adult population Loading dose 200mg to 400mg intravenous. Maintenance dose 200mg to 400mg/day.

Valproate Sodium

Intervention Type DRUG

Pediatric population Loading dose 30mg/kg intravenous. Max dose 3000mg Maintenance dose 20mg to 30mg/Kg/day, Max dose 3000mg/day. Adult population Loading dose 30 mg/kg intravenous. Maintenance dose 20mg to 30mg/Kg/day

Fosphenytoin

Intervention Type DRUG

Pediatric population Loading dose 20 mg phenytoin equivalents (PE)/kg intravenous. Max dose 1500mg PE Maintenance dose 4mg PE/Kg/day. Max dose 300mg PE/day. Adult population Loading dose 20 mg/kg intravenous. Max dose 1500mg PE Maintenance dose 4mg PE/Kg/day.

Seizure network Negative subjects

Participants in this group encompass all SzNET-Negative subjects, including those who are EEG-Positive and EEG-Negative. These participants will not receive interventions after the initial study indicated rs-fMRI. They will neither receive repeat rs-fMRI or repeat EEG.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phenobarbital Sodium Injection

\*This drug can only be selected as part of the intervention for the subgroup of patients with a Glasgow Coma Score of 8 or less.

Loading dose 20 mg/kg intravenous. Max dose 1000mg Maintenance dose 4mg/kg/day. Max dose 300mg/day. Adult population Loading dose 20 mg/kg intravenous. Maintenance dose 4mg/kg/day.

Intervention Type DRUG

Levetiracetam

Pediatric population Loading dose 60 mg/kg intravenous. Max dose 4000mg. Maintenance dose 40mg/Kg/day, Max dose 3000mg/day. Adult population Loading dose 2000mg-4000mg intravenous. Maintenance dose 1500mg to 3000mg/day.

Intervention Type DRUG

Lacosamide Injectable Product

Pediatric population Loading dose 10 mg/kg intravenous, Max dose 400mg. Maintenance dose 4mg to 8mg/Kg/day. Max dose 300mg. Adult population Loading dose 200mg to 400mg intravenous. Maintenance dose 200mg to 400mg/day.

Intervention Type DRUG

Valproate Sodium

Pediatric population Loading dose 30mg/kg intravenous. Max dose 3000mg Maintenance dose 20mg to 30mg/Kg/day, Max dose 3000mg/day. Adult population Loading dose 30 mg/kg intravenous. Maintenance dose 20mg to 30mg/Kg/day

Intervention Type DRUG

Fosphenytoin

Pediatric population Loading dose 20 mg phenytoin equivalents (PE)/kg intravenous. Max dose 1500mg PE Maintenance dose 4mg PE/Kg/day. Max dose 300mg PE/day. Adult population Loading dose 20 mg/kg intravenous. Max dose 1500mg PE Maintenance dose 4mg PE/Kg/day.

Intervention Type DRUG

Other Intervention Names

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phenobarbital Valproate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilio G. Cediel, MD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Varina L Boerwinkle, MD

Role: STUDY_CHAIR

UNC-Chapel Hill

Locations

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UNC Health

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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23-0157

Identifier Type: -

Identifier Source: org_study_id