MRgFUS for Childhood Epilepsy

March 23, 2026 updated by: George Ibrahim, The Hospital for Sick Children

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Age 4 - 17 years at time of enrollment • A confirmed diagnosis of epileptogenic lesion refractory to medication therapy. • Diagnosis of intractable epilepsy with failure after trial of two anti-epileptic medications. • Able to fit into a standard MRI unit. • Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk. • Patients with a head circumference >52cm and can tolerate frame-based stereotaxy. • Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records. • The epileptogenic lesions (HH or other) can be targeted by the Exablate device. The lesion and region of treatment must be apparent on MRI and CT such that image fusion can delineate and model targeting when registered to the Exablate device.

Exclusion Criteria:

• Any contraindication to MRI scanning • Pregnancy • Evidence of ethanol or substance abuse • Significant cardiac, respiratory, renal, or endocrine conditions (including arrhythmias) that increase procedural risk • History of abnormal bleeding disorders or hemorrhage • Use of anticoagulant, antiplatelet, or hemorrhage-associated medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRgFUS Treatment
MRgFUS treatment of epileptogenic brain lesions
Procedure: Ablation
MRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.
Other Names:
  • ExAblate Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engel Epilepsy Surgery Outcome Score
Time Frame: baseline, 7 days, 1 month, 6 months, 1 year

A standard method to classify the post-operative outcomes for epilepsy surgery using the following outcome scale:

  • Class I: Free of disabling seizures.
  • Class II: Rare disabling seizures ("almost seizure free").
  • Class III: Worthwhile improvement.
  • Class IV: No worthwhile improvement.
baseline, 7 days, 1 month, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Severity Questionnaire (SSQ)
Time Frame: baseline, 7 days, 1 month, 6 months, 1 year

A 22-item questionnaire to evaluate seizure severity and changes in seizure severity following treatment. Items are individually scored on a scale from 1-7.

Higher scores indicate greater seizure severity.
baseline, 7 days, 1 month, 6 months, 1 year
Quality of Life in Childhood Epilepsy (QOLCE)
Time Frame: baseline, 7 days, 1 month, 6 months, 1 year
A parent-reported questionnaire measuring the quality of life in children with epilepsy. Scored on a scale of 0 to 100. Higher scores indicate a higher quality of life.
baseline, 7 days, 1 month, 6 months, 1 year
KIDSCREEN-27
Time Frame: baseline, 7 days, 1 month, 6 months, 1 year

A 27-item scale that measures a child's well being-including physical health, emotions, friendships, and school life-to assess health-related quality of life.

Scores range from 0 to 100. Higher scores indicate better quality of life.
baseline, 7 days, 1 month, 6 months, 1 year
Burden Scale for Family Caregivers (BSFC-s)
Time Frame: baseline, 7 days, 1 month, 6 months, 1 year
A brief survey of parental burden of care. Scores range from 0 to 30, with higher scores indicating a greater burden.
baseline, 7 days, 1 month, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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