Efficacy of taVNS Versus Sham Stimulation in Reduing Depressive Symptoms in Patients With Epilepsy: a Multi-center, Double-blinded, Randomized, 20-week, Parallel-arm, Superiority Study
NCT ID: NCT06794034
Last Updated: 2025-01-27
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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ACTIVE_NOT_RECRUITING
NA
158 participants
INTERVENTIONAL
2023-04-01
2025-12-31
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
TRIPLE
Study Groups
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"xinlepai","taVNS" 25Hz
The "xinlepai", a transcutaneous auricular vagus nerve stimulator (taVNS), was used with a stimulation frequency of 25Hz, combined with conventional treatment. Use 3 times daily for 30 minutes each time.
Intervention
taVNS 25Hz+routine treatment, three times daily, 30 mins
"xinlepai","taVNS" 1Hz
The "xinlepai", a transcutaneous auricular vagus nerve stimulator (taVNS), was used with a stimulation frequency of 1Hz, combined with conventional treatment. Use 3 times daily for 30 minutes each time.
Sham Comparator
taVNS 1Hz+routine treatment, three times daily, 30 mins
Interventions
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Intervention
taVNS 25Hz+routine treatment, three times daily, 30 mins
Sham Comparator
taVNS 1Hz+routine treatment, three times daily, 30 mins
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of epilepsy (based on 2014 definition by ILAE)
* Having comorbidity with mild-moderate depression (confirmed diagnosis by a psychiatrist)
* Willing and able to provide informed conset
Exclusion Criteria
* Those with severe depression or anxiety who are in urgent need of psychiatric care
* Those who are imminently suicidal or unable to keep themselves safe
* Those experiencing severe cognitive difficulties with day-to-day memory, attention, and ability to learn basic information
* Those having a pacemaker, a invasive vagus nerve stimulator, or a metal implant
* The pinna is not suitable for earplugs
* Pregnancy
18 Years
ALL
No
Sponsors
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
First Affiliated Hospital of Zhejiang University
OTHER
Jinhua Second Hospital
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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yi guo
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First People's Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Second Hospital
Jinhua, Zhejiang, China
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, China
The Fourth Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, China
Countries
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Other Identifiers
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2023-0182
Identifier Type: -
Identifier Source: org_study_id
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