Electrical stimulation of the subthalamic nucleus 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

This study is testing if deep brain stimulation can help people with drug-resistant focal motor epilepsy have fewer seizures compared to those who receive a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06248333 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of deep brain stimulation (DBS) of the subthalamic nucleus (STN) as an adjunctive therapy for patients with drug-resistant focal motor epilepsy. It is a multicenter, randomized, double-blind, sham-controlled trial where participants will be assigned to either active STN-DBS or sham stimulation. The primary goal is to compare the frequency of seizures between the two groups. The study will be conducted at five high-volume centers in China, ensuring a robust analysis of the intervention's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-65 who have refractory focal motor epilepsy and have not responded to anti-seizure medications.

Not a fit: Patients who do not have focal motor epilepsy or are not refractory to anti-seizure medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency in patients with drug-resistant focal motor epilepsy.

How similar studies have performed: Other studies have shown promise with deep brain stimulation for epilepsy, but this specific approach targeting the subthalamic nucleus is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital, Beijing — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Liankun Ren, MD — Xuanwu Hospital, Beijing
• Study coordinator: Liankun Ren, MD

Conditions Epilepsy, Drug Resistant; Deep Brain Stimulation; Drug Resistant Epilepsy; Subthalamic Nucleus; Focal Motor Epilepsy