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Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT07128563•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

Detailed Description

This project aims to include 5 participants, and evaluate the effectiveness and safety of piriform cortex stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Key Dates

Start Date

September 10, 2025

Primary Completion Date

September 1, 2026

Completion Date

August 1, 2027

Last Updated

August 19, 2025

Enrollment

ESTIMATED participants

Conditions

Epilepsy, Drug Resistant

Interventions

piriform cortex-DBS

DEVICE

Contacts

Liankun Ren, MD

CONTACT

+86 13681576621 renlk2022@outlook.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Deep Brain Stimulation Post Failed Vagal Nerve Stimulation