Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

Inclusion Criteria14

• -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.