NCT06794034

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

November 17, 2024

Last Update Submit

January 20, 2025

Conditions

Depressive Symptoms in Patients With Epilepsy

Keywords

transcutaneous auricular vagus nerve stimulationepilepsydepression

Outcome Measures

Primary Outcomes (1)

  • 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

    at 20th week

Secondary Outcomes (8)

  • Depression remission proportion

    at 20th week

  • Anxiety

    at 20th week

  • Seizure frequency

    at 20th week

  • Seizure severity

    at 20th week

  • Sleep quality

    at 20th week

  • +3 more secondary outcomes

Study Arms (2)

"xinlepai","taVNS" 25Hz

EXPERIMENTAL

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.

Device: Intervention

"xinlepai","taVNS" 1Hz

SHAM COMPARATOR

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.

Device: Sham Comparator

Interventions

InterventionDEVICE

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

"xinlepai","taVNS" 25Hz
Sham ComparatorDEVICE

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

"xinlepai","taVNS" 1Hz

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

The First People's Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

Location

Jinhua Second Hospital

Jinhua, Zhejiang, 321000, China

Location

Ningbo Medical Center Li Huili Hospital

Ningbo, Zhejiang, 315040, China

Location

The Fourth Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

EpilepsyDepression

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • yi guo

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The device provider assigns the device directly to the patient for training and use after allocation. All the scales will be assessed by the same site assessor, who has undergone consistency training. The doctors, patients, scale assessors and statisticians are all blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2024

First Posted

January 27, 2025

Study Start

April 1, 2023

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2024-11

Locations

CN(5)