Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

NCT06663124

Epilepsy, Drug Resistant

NOT_YET_RECRUITING NA

Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)

NCT06436547

Epilepsy, Drug Resistant

ACTIVE_NOT_RECRUITING NA

Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy

NCT06593444

Epilepsy (treatment Refractory)

NOT_YET_RECRUITING NA

Electrical Brain Stimulation to Reduce Epileptic Seizures

NCT00344877

Temporal Lobe Epilepsy

COMPLETED

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy

NCT02602899

Refractory Epilepsy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy, Drug Resistant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After completion of DBS surgery (Month 0), participants will undergo an 8-day parameter exploration period after 1-month postoperative recovery (month 1), and DBS off after individual parameters have been determined. At Month 2, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (Activate Stimulation) will have their stimulator turned on after randomization. Group B (Sham Stimulation) will receive sham stimulation, meaning the stimulator will remain off until Study Month 5. At Month 5, Group A will continue to receive stimulation and not have the stimulator turned off, and the stimulator in Group B will be turned on and left on for the remainder of the study (Month 11).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

One day before the first programming, the grouper and the programmer will release the cover independently. Only the grouper and the programmer will know the group information of each patient, in which the programmer does not communicate with the patient about the programming parameters. After each programming, the results are uniformly placed in the programmer to keep the others (patients, neurologists) blind about grouping and parameters. The evaluation will be finished by neurologists, who do not participate in the surgical treatment and programmer. So that the participants, care providers, investigators, and outcomes assessors will not know which group are assigned to from randomization (Month 2) to Month 5. The statistical team is independent of other researchers.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

STN-DBS ON

Intervention Type DEVICE

Stimulation ON

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.

Group Type SHAM_COMPARATOR

STN-DBS OFF

Intervention Type DEVICE

Stimulation OFF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STN-DBS ON

Stimulation ON

Intervention Type DEVICE

STN-DBS OFF

Stimulation OFF

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
2. 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.
3. 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.

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;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
* Pregnant, or planning to pregnant within 2 years;
* Participation in another clinical study within 3 months;
* Not suitable for enrollment as assessed by the multidisciplinary team of the center.

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No