Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
ConditionEpilepsy, Drug Resistant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing
About this 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.
Eligibility criteria
Qualifiers
14-65 years of age, inclusive, at Screening Visit.
Refractory to anti-seizure medications (ASMs).
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- STN-DBS ON
- STN-DBS OFF
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Peking University
Collaborator
Source ClinicalTrials.gov