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Clinical Trials in China / NCT06794034
Active, not recruiting Not applicable

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

NCT06794034 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (5)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT06794034 on ClinicalTrials.gov ↗ ← All trials in China