Actively Recruiting
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
Led by Xuanwu Hospital, Beijing · Updated on 2025-07-15
33
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 65 years at screening.
- Diagnosis of drug-resistant focal motor epilepsy.
- Seizures mainly presenting as focal tonic, myoclonic, or primary motor seizures, with or without secondary bilateral tonic-clonic seizures.
- Epileptogenic zone predominantly in the unilateral or bilateral central area or supplementary motor area based on presurgical evaluation.
- At least 3 focal onset seizures within 1 month before screening.
- Receiving at least one anti-seizure medication with a stable regimen (dose adjustments allowed; no additions or removals except brief rescue medicines).
- Ability of patient or caregiver to complete seizure diary.
- Seizure diary showing an average of 3 or more partial-onset seizures per month during the 3-month baseline period, with no more than 30 days between seizures.
- Considered unsuitable for or refusing resection surgery or unsatisfactory results from epileptic focus resection or thermocoagulation surgery.
- Signed informed consent.
You will not qualify if you...
- Diagnosis of generalized or hereditary epilepsy with ion channel gene mutations.
- Seizures mainly presenting as complex motor seizures such as hyperkinetic or automatisms.
- Tonic-clonic status epilepticus within the past 12 months.
- Psychogenic non-epileptic seizures within the past 12 months.
- Structural lesion of the subthalamic nucleus.
- Presence of implanted electrical stimulation devices (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or metallic implants in the head, except stable vagal nerve stimulators.
- Risk factors for intraoperative or postoperative bleeding or need for chronic anticoagulation or antiplatelet therapy.
- IQ below 55 or severe cognitive dysfunction preventing study completion.
- Progressive neurological disorders.
- Severe neuropsychiatric disorders such as dementia, major depression requiring psychiatric admission within 5 years, suicidal or self-injurious tendencies, schizophrenia, or neurodegenerative disorders.
- Serious physical disorders or severe liver or kidney dysfunction.
- Pregnant or planning pregnancy within 2 years.
- Participation in another clinical study within 3 months.
- Deemed unsuitable for enrollment by the multidisciplinary team.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
L
Liankun Ren, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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