Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248333
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-01-14
Brief Title:
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy A Multicenter Randomized Double-blind Sham-controlled Parallel-group Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEM
Brief 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None