Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
Opening soon NCT07010276
Run by The Hospital for Sick Children · for 5 to 17 · All sexes
What this study is about
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
Who can join (things the study team will check)
✅ You may be able to join if…
- Female or Male patients 5 years of age and over (17 and 11 months), not including 18 years old
- Diagnosis of drug-resistant epilepsy with failure after trial of two anti-epileptic
- Medications (as defined by Kwan et al. 20093). All children screened for entry into the study will be re-diagnosed by a neurologist prior to entry.
- Main seizure type includes epileptic spasms and tonic spasms, as confirmed by electroencephalography.
- Parents or legal guardians, including caregivers, are informed and able to give written consent.
- Ability to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study
🚫 You may not be able to join if…
- Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to MRI scanning. A preoperative MRI scan is essential to
- Planning DBS and therefore any contraindication to MRI is a contraindication to enrollment in the study.
- Unwillingness or inability to return to SickKids for follow-up visits.
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
- Pregnancy
- Inability to communicate adequately in English in order to complete the baseline and follow-up questionnaires.
- A co-morbid condition that requires frequent MRI scanning as part of the patient's regular care.
Where this trial is running
- The Hospital for Sick Children, Toronto, Ontario, Canada
Who to contact
George M Ibrahim, MD, PhD · 416-813-6125 · george.ibrahim@sickkids.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07010276.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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