Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT07010276, who can take part
Where in Canada
- The Hospital for Sick ChildrenToronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Hospital for Sick Children
- Trial code
- NCT07010276
- Record updated
- 12 June 2025
- Original description
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control TrialRead full original descriptionShow less
Centromedian Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Trial
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
Inclusion: 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.
Exclusion: Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure; A co-morbid condition that requires frequent MRI scanning as part of the patient's regular care; 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; Pregnancy; Inability to communicate adequately in English in order to complete the baseline and follow-up questionnaires.