Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

Early Phase 1UnknownNCT02378792

Beijing Pins Medical Co., Ltd300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Refractory Epilepsy

Interventions

Vagus Nerve StimulationDEVICE

Vagus Nerve Stimulator

Eligibility

Sex: ALLMin age: 6 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (5)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

The first hospital of jilin university

Changchun, Jilin, China

RECRUITING

The general of shenyang military

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: At12,24 months

Changes from Basline in the Engel and McHugh description

Time frame: At 12,24 months

Changes from Basline in 24 hour ECG description

Time frame: At 12,24 months

Central Contacts

Jia Fumin, PhD

CONTACT

+86 010-59361265 pins_medical@163.com

Li Luming, PhD

CONTACT

+86 010-60736388

Data from ClinicalTrials.gov

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