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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02632149
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : October 11, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Device: PINS Vagus Nerve Stimulator Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vagus nerve Stimulation is on Device: PINS Vagus Nerve Stimulator


Outcome Measures

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

Secondary Outcome Measures :
  1. Changes in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 1,3,6,months of stimulation ]
  2. Change from Baseline in the Engel and McHugh description [ Time Frame: At 1,3,6 months ]
  3. Overall WISC Score in Patients from Baseline [ Time Frame: Mean change from baseline WISC Overall Score at 1,3,6months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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): 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
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 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