NCT07497178

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Mar 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Dec 2029

Study Start

First participant enrolled

March 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

March 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Drug Resistant EpilepsyEpilepsy

Keywords

EpilepsyDREMRI-guided focused ultrasoundMRgFUS

Outcome Measures

Primary Outcomes (1)

  • Engel Epilepsy Surgery Outcome Score

    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 Outcomes (4)

  • Seizure Severity Questionnaire (SSQ)

    baseline, 7 days, 1 month, 6 months, 1 year

  • Quality of Life in Childhood Epilepsy (QOLCE)

    baseline, 7 days, 1 month, 6 months, 1 year

  • KIDSCREEN-27

    baseline, 7 days, 1 month, 6 months, 1 year

  • Burden Scale for Family Caregivers (BSFC-s)

    baseline, 7 days, 1 month, 6 months, 1 year

Study Arms (1)

MRgFUS Treatment

OTHER

MRgFUS treatment of epileptogenic brain lesions

Procedure: Ablation

Interventions

AblationPROCEDURE

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

Also known as: ExAblate Neuro
MRgFUS Treatment

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug Resistant EpilepsyEpilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

George M Ibrahim, MD, PhD

CONTACT

416-813-6125george.ibrahim@sickkids.ca

Adam C Waspe, PhD

CONTACT

416-813-7500adam.waspe@sickkids.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. George M. Ibrahim, MD, PhD

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

March 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share