Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy (VNSRE)

October 11, 2016 updated by: Beijing Pins Medical Co., Ltd

The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Kan Xu, MD
        • Contact:
          • Jiqing Qiu
    • Liaoning
      • Shenyang, Liaoning, China, 110011
        • Recruiting
        • The general of shenyang military
        • Contact:
          • Guobiao Liang, MD
        • Contact:
          • Guanqian Yuan
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu hospital of shandong university
        • Contact:
          • Shujun Xu, MD
        • Contact:
          • Wenhua Zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Weiming FU, MD
        • Contact:
          • Junming Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vagus Verve Stimulation is on
Device: Vagus Nerve Stimulation
Vagus Nerve Stimulator
Other Names:
  • PINS Stimulator System
SHAM_COMPARATOR: Placebo Vagus Verve Stimulation is off
Device: Vagus Nerve Stimulation
Vagus Nerve Stimulator
Other Names:
  • PINS Stimulator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
Time Frame: 4,8,12,16,20,24 months of stimulation
4,8,12,16,20,24 months of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluvation period
Time Frame: 4,8,12,16,20,24 months of stimulation
Changes in seizure frequency from baseline to 4,8,12,16,20,24 months
4,8,12,16,20,24 months of stimulation
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Time Frame: Mean change from baseline QOLIE-31 Overall Score at 12,24 months
QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Mean change from baseline QOLIE-31 Overall Score at 12,24 months
Changes in the Number of Anti-epileptic Drugs Prescribed
Time Frame: At12,24 months
Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
At12,24 months
Changes from Basline in the Engel and McHugh description
Time Frame: At 12,24 months
At 12,24 months
Changes from Basline in 24 hour ECG description
Time Frame: At 12,24 months
At 12,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (ESTIMATE)

March 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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