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.
Eligible Conditions
- Localization-related Epilepsy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 0 Secondary · Reporting Duration: 1.5 years
1 month
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
1.5 years
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 prediction of eloquent white matter pathways providing no postoperative deficits that will be assessed at 1.5 years after surgery
Strength of association between local efficiency change of contralateral verbal-/non-verbal IQ network and verbal-/non-verbal IQ change that will be measured between 1 month before surgery and 1.5 years after surgery
Strength of association between local efficiency of preoperative network and functional measure: full-scale IQ, verbal-IQ, non-verbal IQ, expressive language, receptive language, and motor function that will be assessed at 1.5 years after surgery
During procedure
Accuracy of DCNN tract classification for detection of ESM-defined eloquent white matter pathways in healthy controls
Within 1 day
Strength of association between local efficiency of preoperative full-scale IQ network and epilepsy duration that will be assessed at the time of preoperative MRI (Hypothesis 2.2)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Patients with drug-resistant epilepsy
1 of 1
Experimental Treatment
60 Total Participants · 1 Treatment Group
Primary Treatment: Neuro-psychology testing · No Placebo Group · N/A
Patients with drug-resistant epilepsyExperimental Group · 2 Interventions: Neuro-psychology testing, Brain magnetic resonance imaging · Intervention Types: Behavioral, DiagnosticTest
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1.5 years
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
288 Previous Clinical Trials
104,595 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,577,377 Total Patients Enrolled
Eligibility Criteria
Age 3 - 19 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:A person must be between the ages of 3 and 19, and have had epilepsy for at least two years.
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Conditions
Cancer Related
Treatments