The Clinical Research on PINS Vagus Nerve Stimulator for Treatment of Lennox-Gastaut in Children

Beijing Pins Medical Co., Ltd5 sites in 1 country31 target enrollmentOctober 2016

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Lennox-Gastaut Syndrome
Sponsor: Beijing Pins Medical Co., Ltd
Enrollment: 31
Locations: 5
Primary Endpoint: Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Last Updated: 9 years ago

The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

October 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Age 3-14 year
•Lennox - Gastaut syndrome diagnostic standard
•Regular drug treatment is invalid
•Antiepileptic drug stability in recent 3 months
•Good health except epilepsy
•Patients or his(her) familyscould understand this method and sign the informed consent
•Patients with good compliance and could complete postoperative follow-up.

•Results of MRI remind epilepsy caused by intracranial space-occupying lesions
•Had epileptic foci excision surgery or corpus callosum
•The vagus nerve lesion and damage
•Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
•Participated in other clinical drug test subjects within three months
•The researchers think that is not suitable for participants'

Changes in seizure frequency from baseline to the seizure count evaluation period 6 month

Time Frame: 6 month of stimulation

Changes in seizure frequency from baseline to the seizure count evaluation period(1,3,6,months of stimulation)
Change from Baseline in the Engel and McHugh description(At 1,3,6 months)
Overall WISC Score in Patients from Baseline(Mean change from baseline WISC Overall Score at 1,3,6months)