Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
NCT ID: NCT03062514
Last Updated: 2018-01-02
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
NA
84 participants
INTERVENTIONAL
2017-10-09
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental
Subjects'Vagus Nerve stimulator is on always
PINS Vagus Nerve Stimualtor
PINS Vagus Nerve Stimualtor
Control
Subjects'Vagus Nerve stimulator is off from enrollment to 3 month
PINS Vagus Nerve Stimualtor
PINS Vagus Nerve Stimualtor
Interventions
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PINS Vagus Nerve Stimualtor
PINS Vagus Nerve Stimualtor
Eligibility Criteria
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Inclusion Criteria
2. At least 6 seizure per month
3. Refractory Epilepsy
4. In good health except epilepsy
5. Patients or his(her) familyscould understand this method and sign the informed consent
6. Patients with good compliance and could complete postoperative follow-up
Exclusion Criteria
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
4. Cann't write the epilepsy diary
5. Participating other clinical trial
6. Cann't complate the operation
7. Complete the postoperative follow-up
8. Cann't complete the promgramming
3 Years
6 Years
ALL
No
Sponsors
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Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yuwu Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Liping Zou
Role: STUDY_DIRECTOR
Chinese PLA General Hospital
Jianxiang Liao
Role: STUDY_DIRECTOR
Shenzhen Children's Hospital
Qian Chen
Role: STUDY_DIRECTOR
Children's Hospital of The Capital Institute of Pediatrics
Baomin Li
Role: STUDY_DIRECTOR
Qilu Hospital of Shandong University
Yuxing Gao
Role: STUDY_DIRECTOR
Shandong Provincial Hospital
Jianmin Liang
Role: STUDY_DIRECTOR
The First Hospital of Jilin University
Shaoping Huang
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Xi'an Jiaotong University
Fei Yin
Role: STUDY_DIRECTOR
Xiangya Hospital of Central South University
Feng Gao
Role: STUDY_DIRECTOR
The Children's Hospital of Zhejiang University School of Medicine
Yanhui Chen
Role: STUDY_DIRECTOR
Fujian Medical University Union Hospital
XiaoMei SHU
Role: STUDY_DIRECTOR
Zunyi Medical College
Hua Yu
Role: STUDY_DIRECTOR
Shengjing Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Luming Li, PhD
Role: CONTACT
Facility Contacts
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Yuwu Jiang
Role: primary
References
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Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3.
Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4.
Other Identifiers
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PINS-026
Identifier Type: -
Identifier Source: org_study_id
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