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NCT04986683 · ClinicalTrials.gov registry record · NA

Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery

A NA study of Focal Epilepsy, sponsored by Wayne State University.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT04986683 is a NA study of Focal Epilepsy that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 60 participants, below the 165-participant average among 8 other Focal Epilepsy trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04986683, a NA study of Focal Epilepsy, is actively recruiting participants, sponsored by Wayne State University.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This project will test the accuracy of a novel diffusion-weighted magnetic resonance imaging (DWMRI) approach using a deep convolutional neural network (DCNN) to predict an optimal resection margin for pediatric epilepsy surgery objectively. Its primary goal is to minimize surgical risk probability (i.e., functional deficit) and maximize surgical benefit probability (i.e., seizure freedom) by precisely localizing eloquent white matter pathways in children and adolescents with drug-resistant focal epilepsy. This new imaging approach, which will acquire a DWMRI scan before pediatric epilepsy surgery in about 10 minutes without contrast administration (and also without sedation even in young children), can be readily applied to improve preoperative benefit-risk evaluation for pediatric epilepsy surgery in the future. The investigators will also study how the advanced DWMRI-DCNN connectome approach can detect complex signs of brain neuronal reorganization that help improve neurological and cognitive outcomes following pediatric epilepsy surgery. This new imaging approach could benefit targeted interventions in the future to minimize neurocognitive deficits in affected children. All enrolled subjects will undergo advanced brain MRI and neurocognitive evaluation to achieve these goals. The findings of this project will not guide any clinical decision-making or clinical intervention until the studied approach is thoroughly validated.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Brain magnetic resonance imaging
  • BEHAVIORAL Neuro-psychology testing

Study Locations (1)

Michigan

  • Wayne State University/Children's Hospital of Michigan - Detroit

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-08-01
Est. Completion 2026-06-30
Phase NA

Sponsor

Wayne State University

163 total trials

What the Registry Record Tells You About NCT04986683

The ClinicalTrials.gov registry entry for NCT04986683 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 8 other Focal Epilepsy trials with a reported enrollment target (64% lower). The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Focal Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Brain magnetic resonance imaging is the first listed.

NCT04986683 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT04986683 about?

NCT04986683 is a clinical study titled "Diffusion MRI Methods to Minimize Postoperative Deficits in Pediatric Epilepsy Surgery". This project will test the accuracy of a novel diffusion-weighted magnetic resonance imaging (DWMRI) approach using a deep convolutional neural network (DCNN) to predict an optimal resection margin for pediatric epilepsy surgery objectively. Its primary goal is to minimize surgical risk probability ...

What is the current status of trial NCT04986683?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2021-08-01. Estimated completion is 2026-06-30.

What conditions does trial NCT04986683 study?

This clinical trial studies the following conditions: Focal Epilepsy.

What interventions are being tested in trial NCT04986683?

The interventions under investigation include: Brain magnetic resonance imaging (DIAGNOSTIC_TEST), Neuro-psychology testing (BEHAVIORAL).

Who is sponsoring clinical trial NCT04986683?

This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04986683 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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