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

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Lennox-Gastaut Syndrome

Treatments: Device: PINS Vagus Nerve Stimulator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02632149

PINS-017

Details and patient eligibility

About

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

Enrollment: 31 estimated patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

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'

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

Vagus nerve Stimulation is on

Experimental group

Treatment:

Device: PINS Vagus Nerve Stimulator