Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
ConditionEpilepsy; Seizure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorThe Hospital for Sick Children
About this trial
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DBS Arm
- VNS arm
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov