NCT06794034Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 17 Nov 2024
- Start date
- 1 Apr 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Epilepsy
- NCT number
- NCT06794034
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 1 Apr 2023 to the primary completion date, 30 Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those experiencing status epilepticus or frequent seizures requiring emergency medication within the year prior to recruitment
- Those having a pacemaker, a invasive vagus nerve stimulator, or a metal implant
Other illness
- Those with severe depression or anxiety who are in urgent need of psychiatric care
Other
- 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
- The pinna is not suitable for earplugs
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital,School of Medicine,Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First People's Hospital of Jiaxing Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Jinhua Second Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| Ningbo Medical Center Li Huili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Fourth Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Yiwu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.