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

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ClinicalTrials.gov Identifier: NCT02603991
Recruitment Status : Unknown
Verified October 2016 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : November 13, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Tracking Information
First Submitted Date November 9, 2015
First Posted Date November 13, 2015
Last Update Posted Date October 13, 2016
Study Start Date June 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 12, 2015)
  • Respondent rate [ Time Frame: Respondent rate at 3,6,9,12,24 month ]
  • seizure free rate [ Time Frame: seizure free rate at 3,6,9,12, 24 month ]
  • complication [ Time Frame: complication at 3,6,9,12, 24 month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Official Title Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Brief Summary Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Epileptic Encephalopathy
Intervention
  • Procedure: PINS Vagus Nerve Stimulator
    The stimulators are implanted in the body,with the stimulation of the IPG
  • Drug: Levetiracetam
    The best anti-epileptic drugs to patients who participate in this study,Levetiracetam,
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 12, 2015)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02603991
Other Study ID Numbers PINS-015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Beijing Pins Medical Co., Ltd
Study Sponsor Beijing Pins Medical Co., Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Jianguo Zhang, MD Beijing Tiantan Hospital
PRS Account Beijing Pins Medical Co., Ltd
Verification Date October 2016