MRgFUS for Childhood Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablation.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy, Epilepsy. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Cohort Study of High Intensity Focused Ultrasound Ablation for Brain Lesions in Children With Drug Resistant Epilepsy
Overview
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.
Interventions
- Procedure Ablation
MRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.
Primary outcome measures
- Engel Epilepsy Surgery Outcome Score [Time frame: baseline, 7 days, 1 month, 6 months, 1 year]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07497178 · 3510