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 (TIDES)

Zhejiang University

Status: Active, not recruiting

Conditions: Depressive Symptoms in Patients with Epilepsy

Treatments: Device: Sham Comparator; Device: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06794034

2023-0182

Details and patient eligibility

About

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

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 2 patient groups

"xinlepai","taVNS" 25Hz

Experimental group

Description:

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.

Treatment:

Device: Intervention

"xinlepai","taVNS" 1Hz

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Comparator