MRgFUS for Childhood Epilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Ablation
Procedure/SurgeryMRI-guided focused ultrasound ablation (MRgFUS) of central brain lesions in children with drug-resistant epilepsy.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MRgFUS TreatmentOther 1 intervention
Trial outcomes
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.
Time frame
baseline, 7 days, 1 month, 6 months, 1 yearSecondary outcomes
1
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.
Time frame
baseline, 7 days, 1 month, 6 months, 1 year2
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.
Time frame
baseline, 7 days, 1 month, 6 months, 1 year3
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.
Time frame
baseline, 7 days, 1 month, 6 months, 1 year4
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.
Time frame
baseline, 7 days, 1 month, 6 months, 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: