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Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy (VNSRE)

Primary Purpose

Refractory Epilepsy

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

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring PINS VNS Refractory Epilepsy

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 6-60.
  2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
  3. At least 1 seizure per month.
  4. In good health except epilepsy.
  5. With normal MMSE score
  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. The vagus nerve lesion and damage
  3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
  4. Alcohol addiction, smoking, and sleep-related breathing disorders

Sites / Locations

  • Beijing Tiantan HospitalRecruiting
  • The first hospital of jilin universityRecruiting
  • The general of shenyang militaryRecruiting
  • Qilu hospital of shandong universityRecruiting
  • The second affiliated hospital zhejiang university school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vagus Verve Stimulation is on

Placebo Vagus Verve Stimulation is off

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in seizure frequency from baseline to the seizure count evaluvation period
Changes in seizure frequency from baseline to 4,8,12,16,20,24 months
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Changes in the Number of Anti-epileptic Drugs Prescribed
Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Changes from Basline in the Engel and McHugh description
Changes from Basline in 24 hour ECG description

Full Information

First Posted
February 27, 2015
Last Updated
October 11, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02378792
Brief Title
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
Acronym
VNSRE
Official Title
The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
PINS VNS Refractory Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagus Verve Stimulation is on
Arm Type
Experimental
Arm Title
Placebo Vagus Verve Stimulation is off
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation
Other Intervention Name(s)
PINS Stimulator System
Intervention Description
Vagus Nerve Stimulator
Primary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
Time Frame
4,8,12,16,20,24 months of stimulation
Secondary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluvation period
Description
Changes in seizure frequency from baseline to 4,8,12,16,20,24 months
Time Frame
4,8,12,16,20,24 months of stimulation
Title
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Description
QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Time Frame
Mean change from baseline QOLIE-31 Overall Score at 12,24 months
Title
Changes in the Number of Anti-epileptic Drugs Prescribed
Description
Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Time Frame
At12,24 months
Title
Changes from Basline in the Engel and McHugh description
Time Frame
At 12,24 months
Title
Changes from Basline in 24 hour ECG description
Time Frame
At 12,24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6-60. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose. At least 1 seizure per month. In good health except epilepsy. With normal MMSE score 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: Results of MRI remind epilepsy caused by intracranial space-occupying lesions. The vagus nerve lesion and damage Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication Alcohol addiction, smoking, and sleep-related breathing disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
+86 010-59361265
Email
pins_medical@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Luming, PhD
Phone
+86 010-60736388
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD
Phone
010-67096611
Email
Limuxin2011@163.com
Facility Name
The first hospital of jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kan Xu, MD
First Name & Middle Initial & Last Name & Degree
Jiqing Qiu
Facility Name
The general of shenyang military
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobiao Liang, MD
First Name & Middle Initial & Last Name & Degree
Guanqian Yuan
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, MD
First Name & Middle Initial & Last Name & Degree
Wenhua Zhang
Facility Name
The second affiliated hospital zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiming FU, MD
First Name & Middle Initial & Last Name & Degree
Junming Zhu

12. IPD Sharing Statement

Citations:
PubMed Identifier
32471438
Citation
Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.
Results Reference
derived

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Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

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