Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

NCT ID: NCT02378792

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-12-31

Brief Summary

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Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.

Detailed Description

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Conditions

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Refractory Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vagus Verve Stimulation is on

Group Type EXPERIMENTAL

Vagus Nerve Stimulation

Intervention Type DEVICE

Vagus Nerve Stimulator

Placebo Vagus Verve Stimulation is off

Group Type SHAM_COMPARATOR

Vagus Nerve Stimulation

Intervention Type DEVICE

Vagus Nerve Stimulator

Interventions

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Vagus Nerve Stimulation

Vagus Nerve Stimulator

Intervention Type DEVICE

Other Intervention Names

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PINS Stimulator System

Eligibility Criteria

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Inclusion Criteria

1. Age 6-60.
2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
3. At least 1 seizure per month.
4. In good health except epilepsy.
5. With normal MMSE score
6. Patients or his(her) familyscould understand this method and sign the informed consent 7)Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma,mental disease,pepticulcer,diabetes Type 1,bad health etc, and other surgical contraindication
4. Alcohol addiction, smoking, and sleep-related breathing disorders
Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The first hospital of jilin university

Changchun, Jilin, China

Site Status RECRUITING

The general of shenyang military

Shenyang, Liaoning, China

Site Status RECRUITING

Qilu hospital of shandong university

Jinan, Shandong, China

Site Status RECRUITING

The second affiliated hospital zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia Fumin, PhD

Role: CONTACT

+86 010-59361265

Li Luming, PhD

Role: CONTACT

+86 010-60736388

Facility Contacts

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Jianguo Zhang, MD

Role: primary

010-67096611

Kan Xu, MD

Role: primary

Jiqing Qiu

Role: backup

Guobiao Liang, MD

Role: primary

Guanqian Yuan

Role: backup

Shujun Xu, MD

Role: primary

Wenhua Zhang

Role: backup

Weiming FU, MD

Role: primary

Junming Zhu

Role: backup

References

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Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.

Reference Type DERIVED
PMID: 32471438 (View on PubMed)

Other Identifiers

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PINS-012

Identifier Type: -

Identifier Source: org_study_id

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