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NCT07128563

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

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-10

Completion Date

2027-08-01

Last Updated

2025-08-19

Healthy Volunteers

Conditions

Epilepsy, Drug Resistant

Interventions

DEVICE

piriform cortex-DBS

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.

Inclusion Criteria: * 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. * Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy * Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging * Informed consent signed. Exclusion Criteria: * 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; * IQ \< 55 or severe cognitive dysfunction, unable to complete the study; * Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.); * Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders; * Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; * Pregnant, or planning to pregnant within 2 years; * Participation in another clinical study within 3 months; * Not suitable for enrollment as assessed by the multidisciplinary team of the center.