Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
NCT ID: NCT02378792
Last Updated: 2016-10-12
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
300 participants
INTERVENTIONAL
2014-08-31
2017-12-31
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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Vagus Verve Stimulation is on
Vagus Nerve Stimulation
Vagus Nerve Stimulator
Placebo Vagus Verve Stimulation is off
Vagus Nerve Stimulation
Vagus Nerve Stimulator
Interventions
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Vagus Nerve Stimulation
Vagus Nerve Stimulator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
3. At least 1 seizure per month.
4. In good health except epilepsy.
5. With normal MMSE score
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. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma,mental disease,pepticulcer,diabetes Type 1,bad health etc, and other surgical contraindication
4. Alcohol addiction, smoking, and sleep-related breathing disorders
6 Years
60 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Pins Medical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The first hospital of jilin university
Changchun, Jilin, China
The general of shenyang military
Shenyang, Liaoning, China
Qilu hospital of shandong university
Jinan, Shandong, China
The second affiliated hospital zhejiang university school of medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Li Luming, PhD
Role: CONTACT
Facility Contacts
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Kan Xu, MD
Role: primary
Jiqing Qiu
Role: backup
Guobiao Liang, MD
Role: primary
Guanqian Yuan
Role: backup
Shujun Xu, MD
Role: primary
Wenhua Zhang
Role: backup
Weiming FU, MD
Role: primary
Junming Zhu
Role: backup
References
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Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.
Other Identifiers
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PINS-012
Identifier Type: -
Identifier Source: org_study_id
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