Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis

Trial statusNot yet recruiting
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 Piriform cortex as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

Eligibility criteria

Qualifiers

Participants are between the ages of 14 -65 years of age

Refractory to anti-seizure medications (ASMs).

Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month.

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.

Disqualifiers

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;

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;

Trial design

Treatments tested in this trial

  • piriform cortex-DBS

Treatment groups

5 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators