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

ConditionEpilepsy, Drug Resistant

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

piriform cortex-DBS
Device
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral piriform cortex.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

Treatment groups

5 Participants

are divided into 1 treatment group

Group A: piriform cortex-DBS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Seizure frequency (SF28)

Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in open-label phase is defined as SF28 per month during the open-label period. Percent change in seizure frequency=100\*(open-label SF28-baseline SF28)/baseline SF28.

Time frame