Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome

Early Phase 1

• Conditions: Lennox-Gastaut Syndrome
• Interventions: Device: PINS Vagus Nerve Stimulator

• Registration Number: NCT02632149
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Age 3-14 year
2. Lennox - Gastaut syndrome diagnostic standard
3. Regular drug treatment is invalid
4. Antiepileptic drug stability in recent 3 months
5. Good health except epilepsy
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. Had epileptic foci excision surgery or corpus callosum
3. The vagus nerve lesion and damage
4. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma， mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication
5. Participated in other clinical drug test subjects within three months
6. The researchers think that is not suitable for participants'

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vagus nerve Stimulation is on	PINS Vagus Nerve Stimulator	-

Primary Outcome Measures

Name	Time	Method
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month	6 month of stimulation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

JiNing First People's Hospital; 🇨🇳 JiNing, Shandong, China

Linyi People's Hospital; 🇨🇳 Linyi, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 QingDao, Shandong, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China