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

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Refractory Epilepsy

Treatments: Device: Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02378792

PINS-012

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Vagus Verve Stimulation is on

Experimental group

Treatment:

Device: Vagus Nerve Stimulation

Placebo Vagus Verve Stimulation is off

Sham Comparator group

Treatment:

Device: Vagus Nerve Stimulation