Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

Early Phase 1

• Conditions: Refractory Epilepsy
• Interventions: Device: Vagus Nerve Stimulation

• Registration Number: NCT02378792
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Vagus Verve Stimulation is off	Vagus Nerve Stimulation	-
Vagus Verve Stimulation is on	Vagus Nerve Stimulation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Changes in seizure frequency from baseline to the seizure count evaluvation period	4,8,12,16,20,24 months of stimulation	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	Mean change from baseline QOLIE-31 Overall Score at 12,24 months	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	At12,24 months	Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures

Trial Locations

Locations (5)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

The first hospital of jilin university; 🇨🇳 Changchun, Jilin, China

The general of shenyang military; 🇨🇳 Shenyang, Liaoning, China

Qilu hospital of shandong university; 🇨🇳 Jinan, Shandong, China

The second affiliated hospital zhejiang university school of medicine; 🇨🇳 Hangzhou, Zhejiang, China