Antiseizure Medication in Seizure Networks at Early Acute Brain Injury (NCT06081283) | Clinical Trial Compass
TerminatedPhase 4
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury
Stopped: Low recruitment
United States5 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range
18 Months – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pre and Post-intervention Seizure Networks Power Spectrum Medians
Timeframe: At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date.
2
Pre and Post-intervention Seizure Networks Total Volume Medians
Timeframe: At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date.