NCT07497178

MRgFUS for Childhood Epilepsy

A Prospective Cohort Study of High Intensity Focused Ultrasound Ablation for Brain Lesions in Children With Drug Resistant Epilepsy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn if magnetic resonance imaging guided focused ultrasound (MRgFUS) can treat brain lesions causing epilepsy in children with drug resistant epilepsy. The main questions it aims to answer are: Is MRgFUS safe in children with drug-resistant epilepsy due to central brain lesions? Does MRgFUS treatment reduce seizure frequency and severity and improve quality-of-life? Researchers will prospective assess outcomes following MRgFUS in children. Participants undergoing MRgFUS will complete seizure diaries and questionnaires related to seizure severity and quality-of-life.

Detailed description

This is a prospective observational study to study the safety and efficacy of MRgFUS for the treatment of drug-resistant epilepsy in pediatric patients with central epileptogenic brain lesions. Twenty (20) participants will be recruited and enrolled in this study to undergo MRgFUS ablation. Prior to treatment, participants will complete a neurological examination, MRI scan, seizure diaries, and study questionnaires. They will be followed for 1 year after treatment, with visits occurring at the following post-operative timepoints: 7 days, 1 month, 6 months, and 1 year. Study assessments and questionnaires will be completed at each follow-up timepoint, with the exception of seizure diaries that are recorded on an ongoing basis over the course of the study. Expected study duration of 36 months.

Conditions

• Drug Resistant Epilepsy
• Epilepsy

Interventions

Type	Name	Description
PROCEDURE	Ablation	MRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Regulatory

• FDA-regulated device study