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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Beijing Pins Medical Co., Ltd
Sponsor:
Collaborators:
Qilu Hospital of Shandong University
Qingdao University
Linyi People's Hospital
Yantai Yuhuangding Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02632149
First received: December 13, 2015
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Condition Intervention Phase
Lennox-Gastaut Syndrome Device: PINS Vagus Nerve Stimulator Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children

Resource links provided by NLM:


Further study details as provided by Beijing Pins Medical Co., Ltd:

Primary Outcome Measures:
  • Changes in seizure frequency from baseline to the seizure count evaluation period 6 month [ Time Frame: 6 month of stimulation ]

Secondary Outcome Measures:
  • Changes in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 1,3,6,months of stimulation ]
  • Change from Baseline in the Engel and McHugh description [ Time Frame: 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 ]

Estimated Enrollment: 31
Study Start Date: October 2016
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vagus nerve Stimulation is on Device: PINS Vagus Nerve Stimulator

  Eligibility

Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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'
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632149

Contacts
Contact: Fumin Ph D Jia +86 010-59361265 pins_medical@163.con
Contact: Luming Ph Li +86 010-60736388

Locations
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Shujun Xu    0531-82169114      
JiNing First People's Hospital Not yet recruiting
JiNing, Shandong, China, 272002
Contact: Changdi Zhao         
Linyi People's Hospital Not yet recruiting
Linyi, Shandong, China, 276005
Contact: Chang MD Fei         
The Affiliated Hospital of Qingdao University Not yet recruiting
QingDao, Shandong, China
Contact: Peng Sun    0532-96166      
Yantai Yuhuangding Hospital Not yet recruiting
Yantai, Shandong, China, 264000
Contact: Guotai Tang         
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Qilu Hospital of Shandong University
Qingdao University
Linyi People's Hospital
Yantai Yuhuangding Hospital
  More Information

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02632149     History of Changes
Other Study ID Numbers: PINS-017
Study First Received: December 13, 2015
Last Updated: October 7, 2016

Keywords provided by Beijing Pins Medical Co., Ltd:
PINS Vagus Nerve Stimulator

Additional relevant MeSH terms:
Syndrome
Lennox Gastaut Syndrome
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on June 23, 2017