NCT07010276Not yet recruiting
Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
Centromedian Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 May 2025
- Start date
- 24 Nov 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- The Hospital for Sick Children
- Diseases
- Epilepsy
- NCT number
- NCT07010276
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 24 Nov 2025 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.