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Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

NCT06663124•Xuanwu Hospital, Beijing

Summary

Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy

Detailed Description

This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•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;
+2 more criteria

Locations (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 1, 2024

Primary Completion Date

January 1, 2025

Completion Date

November 1, 2026

Last Updated

October 29, 2024

Enrollment

ESTIMATED participants

Conditions

Epilepsy, Drug Resistant

Interventions

EC-DBS ON

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: October 29, 2024Data 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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Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

Inclusion Criteria

Exclusion Criteria

Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

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

Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Deep Brain Stimulation Post Failed Vagal Nerve Stimulation