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 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2025-01-27
Summary
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
Conditions
- Depressive Symptoms in Patients With Epilepsy
Interventions
- DEVICE
-
Intervention
taVNS 25Hz+routine treatment, three times daily, 30 mins
- DEVICE
-
Sham Comparator
taVNS 1Hz+routine treatment, three times daily, 30 mins
Sponsors & Collaborators
-
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
collaborator OTHER -
Ningbo Medical Center Lihuili Hospital
collaborator OTHER_GOV -
First Affiliated Hospital of Zhejiang University
collaborator OTHER -
Jinhua Second Hospital
collaborator UNKNOWN -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Principal Investigators
-
yi guo · Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2025-12-30
- Completion
- 2025-12-31
Countries
- China
Study Locations
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