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Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06248333•Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral tonic-clonic seizure.
•2. 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:
•1. At least 3 focal onset seizures (with or without secondary bilateral tonic-clonic seizure).
•2. 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:
•1. The patient or their caregiver is capable of completing the seizure diary.
+4 more criteria

Exclusion Criteria

•Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
•Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.);
•Tonic-clonic status epilepticus within12 months;
•Psychogenic non-epileptic seizures within 12 months;
•Structural lesion of the subthalamic nucleus;
•Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
•Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
•IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
•Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
•Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
+4 more criteria

Locations (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 14, 2024

Primary Completion Date

December 31, 2025

Completion Date

June 30, 2026

Last Updated

July 15, 2025

Enrollment

ESTIMATED participants

Conditions

Epilepsy, Drug Resistant

Interventions

STN-DBS ON

DEVICE

STN-DBS OFF

DEVICE

Contacts

Liankun Ren, MD

CONTACT

+86 13681576621 renlk2022@outlook.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

Inclusion Criteria

Exclusion Criteria

Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis

Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Deep Brain Stimulation Post Failed Vagal Nerve Stimulation