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
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2023-04-01
Last updated
2025-01-27
Condition(s) studied
Depressive Symptoms in Patients With Epilepsy
Investigational drug(s) / intervention(s)
InterventionSham Comparator
Intervention: taVNS 25Hz+routine treatment, three times daily, 30 mins
Sham Comparator: taVNS 1Hz+routine treatment, three times daily, 30 mins
Study summary
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults age ≥18
* 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 experiencing status epilepticus or frequent seizures requiring emergency medication within the year prior to recruitment
* 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
Primary outcome measure(s)
Depression response proportion — at 20th week depression response proportion=(number of responders/total number of group patients)\*100%, depression response defined as ≥50% reduction in HAMD-17 scores at 20th week
Trial sites (5)
Facility
City
Region
Status
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
The First People's Hospital of Jiaxing
Jiaxing
Zhejiang
Jinhua Second Hospital
Jinhua
Zhejiang
Ningbo Medical Center Li Huili Hospital
Ningbo
Zhejiang
The Fourth Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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