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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02632149

Enrollment

Registered

2015-12-16

Start date

2016-10-31

Completion date

Unknown

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox-Gastaut Syndrome

Keywords

PINS Vagus Nerve Stimulator

Brief summary

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

Interventions

DEVICEPINS Vagus Nerve Stimulator

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 14 Years

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'

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactFumin Ph D Jia

pins_medical@163.con+86 010-59361265

Backup ContactLuming Ph Li

+86 010-60736388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026