Tests brain stimulation for hard-to-control focal motor epilepsy
Tests subthalamic nucleus electrical stimulation in people with drug-resistant focal motor epilepsy.
Plain-language title generated from the registry record
Registry title: Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 65 years old?
Source: NCT06248333, who can take part
Where in China
- Xuanwu Hospital, BeijingBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06248333
- Record updated
- 15 July 2025
- Original description
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.Read full original descriptionShow less
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
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.
Inclusion: 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.
Exclusion: 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; Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations; Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.); Psychogenic non-epileptic seizures within 12 months; 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; 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; Tonic-clonic status epilepticus within12 months; Structural lesion of the subthalamic nucleus; IQ < 55 or severe cognitive dysfunction, unable to complete the study; 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.