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
1 other identifier
interventional
31
1 country
5
Brief Summary
The purpose of this study is to evaluate the clinical effectiveness of PINS vagus nerve stimulatior in children with Lennox-Gastaut Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedOctober 11, 2016
October 1, 2016
1 year
December 13, 2015
October 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
6 month of stimulation
Secondary Outcomes (3)
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
Study Arms (1)
Vagus nerve Stimulation is on
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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'
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Pins Medical Co., Ltdlead
- Qilu Hospital of Shandong Universitycollaborator
- Qingdao Universitycollaborator
- Linyi People's Hospitalcollaborator
- Yantai Yuhuangding Hospitalcollaborator
Study Sites (5)
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
JiNing First People's Hospital
Jining, Shandong, 272002, China
Linyi People's Hospital
Linyi, Shandong, 276005, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2015
First Posted
December 16, 2015
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Last Updated
October 11, 2016
Record last verified: 2016-10