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Antiseizure Medication

Antiseizure Medication for Severe Brain Injury

Phase 4

Recruiting

Led By Emilio G. Cediel, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Acute brain injury by TBI, hypoxic-ischemic insult, cardiac arrest, or stroke by medical chart review

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

Awards & highlights

Study Summary

This trial will explore how antiseizure drugs affect brain connectivity in severe brain injury patients with suppressed consciousness. They will compare pre & post-treatment brain scans to see if seizure networks change.

Who is the study for?

This trial is for ICU patients with severe brain injuries from events like stroke or cardiac arrest, who are stable enough for an MRI but have a Glasgow Coma Scale score under 9. They must be within 3 to 45 days of their injury and not allergic to the study drugs, pregnant, brain dead, have contraindications for MRI scans, epilepsy history, or severe neurological dependence.Check my eligibility

What is being tested?

The study tests if FDA-approved antiseizure medications can change how seizure networks in the brain connect after serious injury. Patients' brains are scanned before and after treatment using rs-fMRI to see if there's any difference in these connections.See study design

What are the potential side effects?

Possible side effects from the antiseizure medications include dizziness, sleepiness, coordination problems, skin rashes or other allergic reactions. Each drug has its own set of potential side effects that could affect different parts of the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with an acute brain injury from a trauma or lack of oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pre and post-intervention seizure networks power spectrum medians

Pre and post-intervention seizure networks total volume medians

Secondary outcome measures

Connectivity improvement of typical resting state networks after intervention

Dropout rate

Enrollment rate

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Seizure network Positive subjectsExperimental Treatment5 Interventions

Participants in this group encompass all SzNET-Positive subjects, including those who are EEG-Positive and EEG-Negative. Within six days of their initial rs-fMRI study, they will receive both loading and maintenance doses of two of the intervention drug regimens from the study's list. Maintenance doses should be administered every 12 hours, commencing 12 hours after the loading dose, with a maximum of 19 maintenance doses allowed. A second rs-fMRI and EEG will be conducted after participants have received at least five maintenance doses. Following these follow-up rs-fMRI and EEG assessments, the use of the intervention drugs as part of the research intervention will be discontinued. However, if medically necessary, these drugs can continue as part of regular therapy. It's important to note that repeat EEG and rs-fMRI assessments cannot be conducted if more than 72 hours have passed since the last dose of the intervention drug regimen.

Group II: Seizure network Negative subjectsActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Valproate Sodium

2019

Completed Phase 3

~40

Levetiracetam

2017

Completed Phase 4

~3990

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,771 Total Patients Enrolled

2 Trials studying Brain Ischemia

74 Patients Enrolled for Brain Ischemia

Emilio G. Cediel, MDPrincipal InvestigatorUNC-Chapel Hill

Varina L Boerwinkle, MDStudy ChairUNC-Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any Seizure network Positive subjects attained FDA approval?

"Taking into consideration the Phase 4 status of this treatment, Power assessed Seizure Network Positive subjects a 3 for safety."

Answered by AI

Does this research endeavor cater to individuals aged 30 and above?

"As specified in the enrollment conditions, the age range to participate is between 6 and 65 years old."

Answered by AI

Does my profile meet the prerequisites for this research endeavor?

"In order to join this study, individuals with TBI should be between 6 and 65 years old. Approximately 54 participants are sought to partake in the trial."

Answered by AI

Are recruitment efforts for this medical experiment still ongoing?

"According to clinicaltrials.gov, this research project is not currently seeking participants and has been dormant since the 6th of October 2023. Nonetheless, there are 2863 alternative trials actively recruiting patients at present."

Answered by AI

What are the overarching goals of this research endeavor?

"The primary objective of this trial is to measure the pre and post-intervention seizure networks total volume medians. Secondary aims include evaluating EEG improvement (as a binary variable categorized as "with improvement" or "without improvement") through expert's qualitative assessment, connectivity enhancement in typical resting state networks after intervention (again, evaluated via an experts opinion) and enrollment rate. All these parameters will be assessed over a time period ranging from 3 to 13 days following the start date of the intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

2023. "Antiseizure Medication in Seizure Networks at Early Acute Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081283.

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