Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome
NCT ID: NCT02632149
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
31 participants
INTERVENTIONAL
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vagus nerve Stimulation is on
PINS Vagus Nerve Stimulator
Interventions
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PINS Vagus Nerve Stimulator
Eligibility Criteria
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Inclusion Criteria
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
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'
3 Years
14 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Qingdao University
OTHER
Linyi People's Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
JiNing First People's Hospital
Jining, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Countries
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Central Contacts
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Luming Ph Li
Role: CONTACT
Facility Contacts
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Shujun Xu
Role: primary
Changdi Zhao
Role: primary
Chang MD Fei
Role: primary
Peng Sun
Role: primary
Guotai Tang
Role: primary
Other Identifiers
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PINS-017
Identifier Type: -
Identifier Source: org_study_id
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