Suspended

Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

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What is being tested

G114R VNS system

Device
Who is being recruted

Drug Resistant Epilepsy+2

+ Brain Diseases

+ Central Nervous System Diseases

Over 3 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorBeijing Pins Medical Co., Ltd
Study ContactJianguang Sun
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2021

Actual date on which the first participant was enrolled.

This study focuses on a new treatment option for individuals with epilepsy that does not respond to medications. The goal is to evaluate the effectiveness of a rechargeable implantable device called the Model G114R Vagus Nerve Stimulation (VNS) system, developed by Beijing PINS Medical. This device is designed to help reduce seizure frequency and improve the quality of life for those affected by drug-resistant epilepsy. The study is important because finding effective treatments for epilepsy that does not respond to standard medications remains a significant challenge. Participants in the study will receive the VNS system implant and will be closely monitored in an epilepsy monitoring unit (EMU) for up to five days. This allows researchers to observe changes in seizure activity and any immediate effects of the treatment. Participants will also have a follow-up after three months to further evaluate the impact of the device on seizure frequency and overall quality of life. Any side effects or adverse events experienced by participants will be carefully recorded throughout the trial to ensure safety and assess any risks associated with the treatment.

Official TitleRechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy
NCT05993117
Principal SponsorBeijing Pins Medical Co., Ltd
Study ContactJianguang Sun
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

20 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.

Over 3 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 DiseasesEpilepsyNervous System Diseases

Criteria

9 inclusion criteria required to participate
Age: ≥3 years old; gender is not limited;
Patients with clinically diagnosed drug-resistant epilepsy, suitable for vagus nerve stimulation therapy;
At least 6 seizures per month;
Patients with a history of increased heart rate (tachycardia) associated with seizure onset based on clinical data obtained from medical history, admission/hospital charts, or prior neurophysiologic evaluations;
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17 exclusion criteria prevent from participating
Patients have had a bilateral or left cervical vagotomy;
One or both sides of the vagus nerve have lesions or damage;
Patients have a history of VNS Therapy;
Patients with a history of status epilepticus within 1 year prior to enrollment;
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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

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

Recruiting

Peking University First Hospital

Beijing, ChinaOpen Peking University First Hospital in Google Maps
SuspendedOne Study Center