To directly compare the effectiveness and safety of deep brain stimulation (DBS) vs. vagus nerve stimulation (VNS) in children with drug-resistant epilepsy (DRE) or epileptic spasms.
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.
Age
5–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 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.
Clareo Health | Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
