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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
Healthy Volunteers: f
View:

• 14-65 years of age, inclusive, at Screening Visit.

• Refractory to anti-seizure medications (ASMs).

• Diagnosed with focal motor epilepsy, which meets the following items:

‣ Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral tonic-clonic seizure.

⁃ After a comprehensive evaluation, the epileptogenic zone was presumed to predominantly involve the unilateral or bilateral central area (precentral gyrus, postcentral gyrus, and paracentral lobule) or supplementary motor area according to comprehensive presurgical evaluation.

• Within 1 month prior to the Screening Visit (M-3), the following conditions are met:

‣ At least 3 focal onset seizures (with or without secondary bilateral tonic-clonic seizure).

⁃ Subject is receiving at least one type of ASM\[s\], and the regimen has been stable (no addition or removal of ASM\[s\] \[not counting brief rescue medicines such as benzodiazepines\]; dose adjustments are permitted to ASM\[s\]).

• Within the baseline period (3 months after the Screening Visit \[M-3\]), the following conditions are met:

‣ The patient or their caregiver is capable of completing the seizure diary.

⁃ Seizure diary shows an average of 3 or more partial-onset seizures (with or without secondary bilateral tonic-clonic seizure) per month during the Baseline Period, with no more than 30 days between seizures.

⁃ The regimen of ASM\[s\] has been stable (no addition or removal of ASM\[s\] \[not counting brief rescue medicines such as benzodiazepines\]; dose adjustments are permitted to ASM\[s\]).

• After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.

• Informed consent signed.

Locations
Other Locations
China
Xuanwu Hospital, Beijing
RECRUITING
Beijing
Contact Information
Primary
Liankun Ren, MD
renlk2022@outlook.com
+86 13681576621
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 33
Treatments
Experimental: Active Stimulation
After randomization, participants will undergo STN-DBS ON in the 3-month blinded phase (Month 2 to Month 5) with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
Sham_comparator: Sham Stimulation
After randomization, participants will undergo STN-DBS OFF in the 3-month blinded phase (Month 2 to Month 5) with 0mA current, then the stimulator will be turned on with individual stimulation parameters and left on for the remainder of the study.
Sponsors
Collaborators: Qilu Hospital of Shandong University, Beijing Tiantan Hospital, Peking University, Beijing Sanbo Brain Hospital
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov