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

Primary Purpose

Lennox-Gastaut Syndrome

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
PINS Vagus Nerve Stimulator
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lennox-Gastaut Syndrome focused on measuring PINS Vagus Nerve Stimulator

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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'

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting
  • JiNing First People's Hospital
  • Linyi People's Hospital
  • The Affiliated Hospital of Qingdao University
  • Yantai Yuhuangding Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vagus nerve Stimulation is on

Arm Description

Outcomes

Primary Outcome Measures

Changes in seizure frequency from baseline to the seizure count evaluation period 6 month

Secondary Outcome Measures

Changes in seizure frequency from baseline to the seizure count evaluation period
Change from Baseline in the Engel and McHugh description
Overall WISC Score in Patients from Baseline

Full Information

First Posted
December 13, 2015
Last Updated
October 7, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Qilu Hospital of Shandong University, Qingdao University, Linyi People's Hospital, Yantai Yuhuangding Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02632149
Brief Title
Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
Official Title
The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Qilu Hospital of Shandong University, Qingdao University, Linyi People's Hospital, Yantai Yuhuangding Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lennox-Gastaut Syndrome
Keywords
PINS Vagus Nerve Stimulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagus nerve Stimulation is on
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PINS Vagus Nerve Stimulator
Primary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time Frame
6 month of stimulation
Secondary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluation period
Time Frame
1,3,6,months of stimulation
Title
Change from Baseline in the Engel and McHugh description
Time Frame
At 1,3,6 months
Title
Overall WISC Score in Patients from Baseline
Time Frame
Mean change from baseline WISC Overall Score at 1,3,6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 3-14 year Lennox - Gastaut syndrome diagnostic standard Regular drug treatment is invalid Antiepileptic drug stability in recent 3 months Good health except epilepsy Patients or his(her) familyscould understand this method and sign the informed consent Patients with good compliance and could complete postoperative follow-up. Exclusion Criteria: Results of MRI remind epilepsy caused by intracranial space-occupying lesions Had epileptic foci excision surgery or corpus callosum The vagus nerve lesion and damage Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication Participated in other clinical drug test subjects within three months The researchers think that is not suitable for participants'
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fumin Ph D Jia
Phone
+86 010-59361265
Email
pins_medical@163.con
First Name & Middle Initial & Last Name or Official Title & Degree
Luming Ph Li
Phone
+86 010-60736388
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shujun Xu
Phone
0531-82169114
Facility Name
JiNing First People's Hospital
City
JiNing
State/Province
Shandong
ZIP/Postal Code
272002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changdi Zhao
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276005
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang MD Fei
Facility Name
The Affiliated Hospital of Qingdao University
City
QingDao
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Sun
Phone
0532-96166
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guotai Tang

12. IPD Sharing Statement

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

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