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Diagnostic Test

Advanced MRI Techniques for Epilepsy

N/A
Recruiting
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with drug-resistant focal epilepsy aged 3-19 years planning two-stage epilepsy surgery with subdural electrodes
Healthy control subjects aged 5-19 years with no cognitive, motor, and/or language impairment or clinical elevations on a measure of behavioral problems and a brain MRI interpreted as normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights

Study Summary

This trial will test a new MRI technique to help guide epilepsy surgery in children. The goal is to improve seizure control and minimize neurocognitive deficits.

Who is the study for?
This trial is for children and adolescents aged 3-19 with drug-resistant focal epilepsy who are planning to undergo a specific two-stage surgery, as well as healthy controls aged 5-19. Participants must not have claustrophobia, pervasive developmental or psychiatric conditions predating seizures, significant brain malformations, history of prematurity or hypoxic-ischemic events, hemiplegia, dysmorphic syndromes, or excessive head motion during MRI.Check my eligibility
What is being tested?
The study is testing a new diffusion-weighted MRI technique that aims to improve surgical outcomes in pediatric epilepsy by better identifying critical brain pathways. It uses advanced imaging and neurocognitive tests without the need for contrast agents or sedation. The goal is to reduce postoperative deficits while increasing the chance of seizure freedom.See study design
What are the potential side effects?
Since this trial involves non-invasive MRI scanning and neuropsychological testing rather than medication or invasive procedures, there are minimal side effects expected. However, discomfort from lying still during scans may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3-19 years old with epilepsy not improved by medication, planning a specific surgery.
Select...
I am aged 5-19, healthy, with no cognitive or motor issues, and a normal brain MRI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of DCNN tract classification combined with Kalman analysis to predict optimal margin balancing maximal seizure freedom and minimal functional deficits that will be assessed at 1.5 years after surgery
Accuracy of DCNN tract classification for detection of ESM-defined eloquent area that will be acquired a month after the DCNN tract classification in children with drug-resistant epilepsy
Accuracy of DCNN tract classification for detection of ESM-defined eloquent white matter pathways in healthy controls
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with drug-resistant epilepsyExperimental Treatment2 Interventions
All patients who undergo two-stage epilepsy surgery will receive two longitudinal evaluations of brain MRI and neuropsychology test: a month before surgery and 1.5 years after surgery.

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,719 Total Patients Enrolled
1 Trials studying Epilepsy
80 Patients Enrolled for Epilepsy
National Institutes of Health (NIH)NIH
2,683 Previous Clinical Trials
6,930,798 Total Patients Enrolled
7 Trials studying Epilepsy
479 Patients Enrolled for Epilepsy

Media Library

Brain Magnetic Resonance Imaging (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04986683 — N/A
Epilepsy Research Study Groups: Patients with drug-resistant epilepsy
Epilepsy Clinical Trial 2023: Brain Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04986683 — N/A
Brain Magnetic Resonance Imaging (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986683 — N/A

Frequently Asked Questions

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

How many participants will be included in this research endeavor?

"Affirmative. Clinicaltrials.gov states that this medical experiment, which was made public on August 1st 2021, is currently recruiting participants. Approximately 60 individuals are sought from one clinical site."

Answered by AI

To whom is this research study open for enrollment?

"Candidates between the age of 3 and 19 who have a diagnosis of epilepsy can apply to be included in this trial. In total, 60 participants are sought after for enrollment."

Answered by AI

Is this research project open to participants older than 45 years?

"As stated in the eligibility requirements for this trial, it is open to individuals aged 3 to 19. Furthermore, there are 105 clinical studies available targeting minors and 161 trials involving seniors over 65 years old."

Answered by AI

Is this research study still seeking participants?

"Clinicaltrials.gov records show that this research trial is still enrolling volunteers and was initially posted on August 1st, 2021 before its most recent update dated April 12th 2022."

Answered by AI
~28 spots leftby Jun 2026