Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

Refractory Epilepsy Clinical Trial

— VNSRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02378792
• Other study ID #: PINS-012
• Status: Recruiting
• Phase: Phase 0
• First received: February 27, 2015
• Last updated: October 11, 2016
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: +86 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Device:
• Vagus Nerve Stimulation
Vagus Nerve Stimulator

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	The first hospital of jilin university	Changchun	Jilin
China	The second affiliated hospital zhejiang university school of medicine	Hangzhou	Zhejiang
China	Qilu hospital of shandong university	Jinan	Shandong
China	The general of shenyang military	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month		4,8,12,16,20,24 months of stimulation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Changes from Basline in the Engel and McHugh description		At 12,24 months	No
Secondary	Changes from Basline in 24 hour ECG description		At 12,24 months	No