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Status unknownNCT02632149Updated Oct 11, 2016

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

An Early Phase 1 interventional study of PINS Vagus Nerve Stimulator in Lennox-Gastaut Syndrome, sponsored by Beijing Pins Medical Co., Ltd. Status unknown at 5 sites in China. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2016-10-11.

Sponsored by Beijing Pins Medical Co., Ltd · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
3 Years to 14 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Lennox-Gastaut Syndrome

Keywords

  • PINS Vagus Nerve Stimulator
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In context

Lennox Gastaut Syndrome

64 studies on the registry are indexed under Lennox Gastaut Syndrome; 14 are open to participants now.

This study's planned enrollment of 31 is below the median of 41 across 46 interventional studies indexed under Lennox Gastaut Syndrome.

Browse Lennox Gastaut Syndrome studies →

Lead sponsor

Beijing Pins Medical Co., Ltd is the lead sponsor of 30 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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'
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (estimated)

Study arms

  • Experimental
    Vagus nerve Stimulation is on

    Device: PINS Vagus Nerve Stimulator

Interventions

  • DevicePINS Vagus Nerve Stimulator
06

What researchers measure

Primary outcomes

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

    Time frame: 6 month of stimulation

Secondary outcomes

  1. Changes in seizure frequency from baseline to the seizure count evaluation period

    Time frame: 1,3,6,months of stimulation

  2. Change from Baseline in the Engel and McHugh description

    Time frame: At 1,3,6 months

  3. Overall WISC Score in Patients from Baseline

    Time frame: Mean change from baseline WISC Overall Score at 1,3,6months

07

Study locations

1 of 5 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    • Shujun Xu · Contact · 0531-82169114
    Recruiting
  • JiNing First People's Hospital
    JiNing, Shandong 272002, China
    • Changdi Zhao · Contact
    Not yet recruiting
  • Linyi People's Hospital
    Linyi, Shandong 276005, China
    • Chang MD Fei · Contact
    Not yet recruiting
  • The Affiliated Hospital of Qingdao University
    QingDao, Shandong, China
    • Peng Sun · Contact · 0532-96166
    Not yet recruiting
  • Yantai Yuhuangding Hospital
    Yantai, Shandong 264000, China
    • Guotai Tang · Contact
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02632149
Lead sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Qilu Hospital of Shandong University, Qingdao University, Linyi People's Hospital, Yantai Yuhuangding Hospital
Responsible party
Sponsor
First posted
Dec 16, 2015
Start date
Oct 2016
Primary completion
Oct 2017 (estimated)
Last update
Oct 11, 2016

Study contacts

Fumin Ph D Jia
Contact
pins_medical@163.con
+86 010-59361265
Luming Ph Li
Contact
+86 010-60736388

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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