Drug Resistant Epilepsy, Epilepsy
Conditions
Keywords
Epilepsy, DRE, MRI-guided focused ultrasound, MRgFUS
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.
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
PROCEDUREAblation
MRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engel Epilepsy Surgery Outcome Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Severity Questionnaire (SSQ) | 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. |
| Quality of Life in Childhood Epilepsy (QOLCE) | 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. |
| KIDSCREEN-27 | 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. |
| Burden Scale for Family Caregivers (BSFC-s) | 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. |
Contacts
CONTACTGeorge M Ibrahim, MD, PhD
CONTACTAdam C Waspe, PhD
Outcome results
None listed