Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

October 12, 2016 updated by: Beijing Pins Medical Co., Ltd
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy

Study Type

Observational

Enrollment (Anticipated)

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

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

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients at age 4-18; diagnostic criteria for epilepsia brain disorders; having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and at least 6 seizures per month; patients or his(her) familys could understand this method and sign the informed consent; Patients with good compliance and could complete postoperative follow-up；without the vagus nerve lesion and damagement, progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases, digestive system diseases

Description

Inclusion Criteria:

  1. age 4-18
  2. Diagnostic criteria for epilepsia brain disorders
  3. Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
  4. patients or his(her) families could understand this method and sign the informed consent
  5. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

  1. the vagus nerve lesion and damage
  2. patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
  3. patients'mental state is not stable，
  4. patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
  5. patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
  6. patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials
  7. patients have participated in other clinical trials.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of the score in Quality of Life in Children with Epilepsy
Time Frame: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
QOLCE Scores at 3,6,9,12,18, 24 month of stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Respondent rate
Time Frame: Respondent rate at 3,6,9,12,24 month
Respondent rate at 3,6,9,12,24 month
seizure free rate
Time Frame: seizure free rate at 3,6,9,12, 24 month
seizure free rate at 3,6,9,12, 24 month
complication
Time Frame: complication at 3,6,9,12, 24 month
complication at 3,6,9,12, 24 month

Collaborators and Investigators

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

Sponsor

Beijing Pins Medical Co., Ltd

Investigators

  • Principal Investigator: Jianguo Zhang, MD, Beijing Tiantan 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

June 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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