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

N/AActive Not RecruitingNCT06794034

Second Affiliated Hospital, Zhejiang University, School of Medicine158 enrolled

Overview

The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

158

Conditions

Depressive Symptoms in Patients With Epilepsy

Interventions

InterventionDEVICE

taVNS 25Hz+routine treatment, three times daily, 30 mins

Sham ComparatorDEVICE

taVNS 1Hz+routine treatment, three times daily, 30 mins

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Depression response proportion

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

Time frame: at 20th week

Secondary Outcomes

Depression remission proportion

depression remission proportion=(number of remission patients/total number of group patients)\*100%, depression remission defined as HAMD-17 scores ≤ 7

Time frame: at 20th week

Anxiety

Changes in the 14-item Hamilton Anxiety Scale (HAMA-14) score from baseline.The total score of the HAMA-14 ranges from 0 to 56, with the higher the score, the more serious the anxiety.

Time frame: at 20th week

Seizure frequency

change from baseline in seizure frequency (times per week)

Time frame: at 20th week

Seizure severity

change from baseline in Liverpool Seizure Severity Scale (LSSS) scores.The total score of the LSSS ranges from 0 to 11 points, and the higher the score, the higher the severity of seizures

Time frame: at 20th week

Sleep quality

change from baseline in Pittsburgh Sleep Quality Index (PSQI) scores.The total score of PSQI ranges from 0 to 21, with the higher the score, the worse the sleep quality.

Time frame: at 20th week

Suicidality

change from baseline in the Mini-International Neuropsychiatric Interview (MINI) Suicide Risk Module scores.The MINI Suicide Risk Module has an overall score ranging from 0 to 33, with higher scores associated with higher suicide risk.

Data from ClinicalTrials.gov

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