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Trial record 44 of 4111 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Diseases"

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 : Recruiting
First Posted : November 13, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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

Condition or disease Intervention/treatment
Epileptic Encephalopathy Procedure: PINS Vagus Nerve Stimulator Drug: Levetiracetam

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
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
Study Start Date : June 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • 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,


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Respondent rate [ Time Frame: Respondent rate at 3,6,9,12,24 month ]
  2. seizure free rate [ Time Frame: seizure free rate at 3,6,9,12, 24 month ]
  3. complication [ Time Frame: complication at 3,6,9,12, 24 month ]


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603991


Contacts
Contact: Fumin Jia, PhD +86-010-59361265
Contact: Luming Li, PhD +86 010-60736388

Locations
China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Jianguo Zhang, MD    010-67096611    Limuxin2011@163.com   
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Investigators
Principal Investigator: Jianguo Zhang, MD Beijing Tiantan Hospital

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02603991     History of Changes
Other Study ID Numbers: PINS-015
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Beijing Pins Medical Co., Ltd:
children and adolescents
Prospective cohort study
vagus nerve stimulation
PINS

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Nootropic Agents