Recruiting soon

Extreme Capsule Stimulation for Drug-resistant Epilepsy

What is being tested

EC-DBS ON

Device

Who is being recruted

Drug Resistant Epilepsy+3

+ Brain Diseases

+ Central Nervous System Diseases

From 14 to 65 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorXuanwu Hospital, Beijing

Study ContactLiankun Ren, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

This clinical study focuses on helping people with drug-resistant focal epilepsy, a type of epilepsy that does not respond to medication. The study is testing a technique called deep brain stimulation, targeting a specific brain area known as the Extreme Capsule (EC). The goal is to find the best way to use this stimulation to reduce seizures without affecting language abilities. This research is important as it seeks to find new treatment options for patients who struggle with current epilepsy treatments. Participants in the study will receive electrical stimulation to the EC area of the brain. This is an interventional study, meaning that it involves active treatment rather than observation. The study will explore different patterns and settings of the stimulation to see which are most effective in reducing the abnormal brain activity that causes seizures. While the study aims to find a safe and effective treatment, there might be some risks associated with brain stimulation, and these will be monitored carefully throughout the study.

Official TitleExtreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

NCT06663124

Principal SponsorXuanwu Hospital, Beijing

Study ContactLiankun Ren, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Drug Resistant EpilepsyBrain DiseasesCentral Nervous System DiseasesEpilepsyEpilepsies, PartialNervous System Diseases

Criteria

4 inclusion criteria required to participate

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.

12 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

participants will undergo EC-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Xuanwu Hospital,Capital Medical University

Beijing, ChinaOpen Xuanwu Hospital,Capital Medical University in Google Maps

Recruiting soonOne Study Center