NCT07010276

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial

Detailed description

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.

Conditions

• Epilepsy; Seizure

Interventions

Type	Name	Description
DEVICE	DBS Arm	Patients in the DBS treatment arm will undergo surgical DBS implantation.
DEVICE	VNS arm	Patients in the VNS treatment arm will undergo surgical VNS implantation.

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2025-06-08
• Last updated: 2025-06-12

Locations

1 site across 1 country: Canada