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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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