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

NCT02603991 | Unknown DMC

• 1 other identifier: PINS-015
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

Conditions

Epileptic Encephalopathy

Keywords

children and adolescents; Prospective cohort study; vagus nerve stimulation; PINS

Outcome Measures

Primary Outcomes (1)

• The change of the score in Quality of Life in Children with Epilepsy

  QOLCE Scores at 3,6,9,12,18, 24 month of stimulation

Secondary Outcomes (3)

• Respondent rate

  Respondent rate at 3,6,9,12,24 month

• seizure free rate

  seizure free rate at 3,6,9,12, 24 month

• complication

  complication at 3,6,9,12, 24 month

Interventions

PINS Vagus Nerve Stimulator PROCEDURE

The stimulators are implanted in the body,with the stimulation of the IPG

Levetiracetam DRUG

The best anti-epileptic drugs to patients who participate in this study，Levetiracetam，

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jianguo Zhang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fumin Jia, PhD

CONTACT

+86-010-59361265

Luming Li, PhD

CONTACT

+86 010-60736388

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 13, 2015
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

CN (1)