Trial to Assess Vagus Nerve Stimulation Therapy in Childr... | NCT02632149

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

NCT02632149

Sponsor

Beijing Pins Medical Co., Ltd

Status

Unknown status

Last Update Posted

Oct 11, 2016Estimated

Enrollment

31Estimated

Phase

Early Phase 1

Conditions

Lennox-Gastaut Syndrome

Interventions

PINS Vagus Nerve Stimulator

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 13, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Name	Class
Qilu Hospital of Shandong University	OTHER
Qingdao University	OTHER
Linyi People's Hospital	OTHER
Yantai Yuhuangding Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vagus nerve Stimulation is on	Experimental		Device: PINS Vagus Nerve Stimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PINS Vagus Nerve Stimulator	Device		Vagus nerve Stimulation is on

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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'

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fumin Ph D Jia	Contact	+86 010-59361265		pins_medical@163.con
Luming Ph Li	Contact	+86 010-60736388

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University	Recruiting	Jinan	Shandong	250012	China

Condition Browse Module

MeSH Terms

ID	Term
D065768	Lennox Gastaut Syndrome

Ancestor Terms

ID	Term
D000073376	Epileptic Syndromes
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided