Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
ConditionEpilepsy, Drug Resistant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing
About this trial
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy
Eligibility criteria
Qualifiers
Participants are between the ages of 14 -65 years of age
Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
Persistence of disabling seizures at least 3 times per month or greater,
Informed consent signed.
Disqualifiers
Structural alterations are present in the extreme capsule.
Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
Psychogenic non-epileptic seizures within 12 months;
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;
Trial design
Treatments tested in this trial
- EC-DBS ON
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov