NCT06248333

Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor epilepsy.

Detailed description

This is a multicenter, randomized, double-blind, sham-controlled, parallel-group trial that aims to investigate the efficacy of STN-DBS in reducing the frequency of seizures in drug-resistant focal motor epilepsy. Participants who were eligible for the inclusion criteria and ineligible for the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. The primary purpose of this study is to compare active STN-DBS with sham STN-DBS in reducing seizure frequency. Both intent analysis (ITT) and compliance program set (PPS) were used for analysis. Only high-volume centers with a proven track record will be included. The STEM trial will be conducted in 5 sites in China.

Conditions

• Epilepsy, Drug Resistant

Interventions

Type	Name	Description
DEVICE	STN-DBS ON	Stimulation ON
DEVICE	STN-DBS OFF	Stimulation OFF

Timeline

• Start date: 2024-02-14
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-02-08
• Last updated: 2025-07-15

Locations

1 site across 1 country: China