Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome

October 7, 2016 updated by: Beijing Pins Medical Co., Ltd

The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children

The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

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
    • Shandong
      • JiNing, Shandong, China, 272002
        • Not yet recruiting
        • Jining First People's Hospital
        • Contact:
          • Changdi Zhao
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Shujun Xu
          • Phone Number: 0531-82169114
      • Linyi, Shandong, China, 276005
        • Not yet recruiting
        • Linyi people's hospital
        • Contact:
          • Chang MD Fei
      • QingDao, Shandong, China
        • Not yet recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
          • Peng Sun
          • Phone Number: 0532-96166
      • Yantai, Shandong, China, 264000
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Guotai Tang

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

3 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 3-14 year
  2. Lennox - Gastaut syndrome diagnostic standard
  3. Regular drug treatment is invalid
  4. Antiepileptic drug stability in recent 3 months
  5. Good health except epilepsy
  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. Had epileptic foci excision surgery or corpus callosum
  3. The vagus nerve lesion and damage
  4. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
  5. Participated in other clinical drug test subjects within three months
  6. The researchers think that is not suitable for participants'

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagus nerve Stimulation is on
Device: PINS Vagus Nerve Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time Frame: 6 month of stimulation
6 month of stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluation period
Time Frame: 1,3,6,months of stimulation
1,3,6,months of stimulation
Change from Baseline in the Engel and McHugh description
Time Frame: At 1,3,6 months
At 1,3,6 months
Overall WISC Score in Patients from Baseline
Time Frame: Mean change from baseline WISC Overall Score at 1,3,6months
Mean change from baseline WISC Overall Score at 1,3,6months

Collaborators and Investigators

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

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Qilu Hospital of Shandong University
Qingdao University
Yantai Yuhuangding Hospital
Linyi People's Hospital

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

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-017

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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