Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

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

Official Title
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The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy

Conditions
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Refractory Epilepsy

Intervention / Treatment
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* Device: Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vagus Verve Stimulation is on<br> | Device: Vagus Nerve Stimulation<br>* Vagus Nerve Stimulator<br>* Other names: PINS Stimulator System;|
| Sham Comparator: Placebo Vagus Verve Stimulation is off<br> | Device: Vagus Nerve Stimulation<br>* Vagus Nerve Stimulator<br>* Other names: PINS Stimulator System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month |  | 4,8,12,16,20,24 months of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4,8,12,16,20,24 months of stimulation | 
| 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. | Mean change from baseline QOLIE-31 Overall Score at 12,24 months | 
| 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 | At12,24 months | 
| Changes from Basline in the Engel and McHugh description |  | At 12,24 months | 
| Changes from Basline in 24 hour ECG description |  | At 12,24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PINS VNS Refractory Epilepsy