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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

Must not have

Subject who cannot speak English

Diagnosis of any pervasive developmental or psychiatric condition predating the onset of seizures, including autism spectrum disorder, tic disorders, obsessive-compulsive disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 3-19 years old with epilepsy not improved by medication, planning a specific surgery.

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I am aged 5-19, healthy, with no cognitive or motor issues, and a normal brain MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak English.

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I was diagnosed with a developmental or psychiatric condition like autism before my seizures started.

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I have physical features that suggest a genetic condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met