Drug Resistant EpilepsyNCT07497178
MRgFUS for Childhood Epilepsy
A study testing Ablation in people with Drug Resistant Epilepsy and Epilepsy, run by The Hospital for Sick Children.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Drug Resistant Epilepsy, Epilepsy
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Ablation
- Keywords
- Epilepsy, DRE, MRI-guided focused ultrasound, MRgFUS
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Also called ExAblate Neuro
MRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS Treatment | Other | MRgFUS treatment of epileptogenic brain lesions Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 7 days, 1 month, 6 months, 1 year
Secondary outcomes (4)
Seizure Severity Questionnaire (SSQ)
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.
Measured: baseline, 7 days, 1 month, 6 months, 1 year
Quality of Life in Childhood Epilepsy (QOLCE)
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.
Measured: baseline, 7 days, 1 month, 6 months, 1 year
KIDSCREEN-27
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.
Measured: baseline, 7 days, 1 month, 6 months, 1 year
Burden Scale for Family Caregivers (BSFC-s)
A brief survey of parental burden of care. Scores range from 0 to 30, with higher scores indicating a greater burden.
Measured: baseline, 7 days, 1 month, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Ibrahim, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497178
- Sponsor's protocol ID
- 3510
- Status last verified
- Jan 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of High Intensity Focused Ultrasound Ablation for Brain Lesions in Children With Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07497178
- Acronym / sponsor ID
- 3510
- Conditions
- Drug Resistant Epilepsy, Epilepsy
- Keywords
- Epilepsy, DRE, MRI-guided focused ultrasound, MRgFUS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgFUS Treatment | Other | Procedure: AblationMRgFUS treatment of epileptogenic brain lesions |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAlso: ExAblate NeuroMRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy. | Procedure or surgery | MRgFUS Treatment |
Primary outcome
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.
4 secondary outcomes
Seizure Severity Questionnaire (SSQ)
Time frame: 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
KIDSCREEN-27
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Drug Resistant Epilepsy and Epilepsy, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George M Ibrahim, MD, PhD (416-813-6125, george.ibrahim@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engel Epilepsy Surgery Outcome Score (time frame: baseline, 7 days, 1 month, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.