Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
NCT ID: NCT07010276
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-11-24
2027-12-31
Brief Summary
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Detailed Description
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This will be an open, non-blinded randomized control trial. Twenty (20) patients will be recruited and enrolled in this pilot study from SickKids.
Expected study duration is 36-48 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VNS Treatment
Patients in the VNS treatment arm will undergo surgical VNS implantation.
VNS arm
Patients in the VNS treatment arm will undergo surgical VNS implantation.
DBS Treatment
Patients in the DBS treatment arm will undergo surgical DBS implantation.
DBS Arm
Patients in the DBS treatment arm will undergo surgical DBS implantation.
Interventions
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DBS Arm
Patients in the DBS treatment arm will undergo surgical DBS implantation.
VNS arm
Patients in the VNS treatment arm will undergo surgical VNS implantation.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
5 Years
17 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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George Ibrahim
Staff Neurosurgeon
Principal Investigators
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George M Ibrahim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1000080101
Identifier Type: -
Identifier Source: org_study_id
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