Clinical trial NCT06794034: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Symptoms in Patients With Epilepsy
Keywords: transcutaneous auricular vagus nerve stimulation
epilepsy
depression
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Ningbo Medical Center Lihuili Hospital
name: First Affiliated Hospital of Zhejiang University
name: Jinhua Second Hospital
First posted: 2025-01-27
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Depression response proportion
timeFrame: at 20th week
Secondary outcomes:
measure: Depression remission proportion
timeFrame: at 20th week
measure: Anxiety
timeFrame: at 20th week
measure: Seizure frequency
timeFrame: at 20th week
measure: Seizure severity
timeFrame: at 20th week
measure: Sleep quality
timeFrame: at 20th week
measure: Suicidality
timeFrame: at 20th week
measure: Quality of life
timeFrame: at 20th week
measure: Adverse events
timeFrame: at 4th 、8th、12th、16th、20th 、22th week
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Jiaxing
country: China
facility: The First People's Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Second Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Li Huili Hospital
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: yi guo
role: PRINCIPAL_INVESTIGATOR
References: