The Effectiveness and Safety of Vagus Nerve Stimulation for TRE
NCT ID: NCT04198207
Last Updated: 2024-12-19
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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COMPLETED
70 participants
OBSERVATIONAL
2019-12-10
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VNS Group
VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.
No interventions assigned to this group
Control Group
Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
* Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
* Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.
Exclusion Criteria
* Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
* Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
* Drug Allergy: Known allergy to drugs used in the study.
* Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
* Pregnancy or Lactation: Pregnant or breastfeeding individuals.
* Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.
1 Year
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
The First Hospital of Jilin University
OTHER
Xuanwu Hospital, Beijing
OTHER
Capital Medical University
OTHER
Peking University First Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Chinese PLA General Hospital
OTHER
Fourth Medical Center of PLA General Hospital
OTHER
Capital Institute of Pediatrics, China
OTHER
The Second Hospital of Hebei Medical University
OTHER
Xijing Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Children's Hospital of Fudan University
OTHER
RenJi Hospital
OTHER
Jining Medical University
OTHER
Xiamen Humanity Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Wuhan Medical Care Center for Women and Children
UNKNOWN
Guangdong 999 Brain Hospital
OTHER
Shenzhen Children's Hospital
OTHER_GOV
Army Medical University, China
OTHER
West China Hospital
OTHER
Beijing Children's Hospital
OTHER
Responsible Party
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Shuli Liang
Director of Functional Neurosurgery
Locations
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Beijing Children's Hospital
Beijing, , China
Countries
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Other Identifiers
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TRE-VNS
Identifier Type: -
Identifier Source: org_study_id