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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 158
- Locations
- 5
- Primary Endpoint
- Depression response proportion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
"xinlepai","taVNS" 25Hz
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.
Intervention: Intervention (Device)
"xinlepai","taVNS" 1Hz
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.
Intervention: Sham Comparator (Device)
Outcomes
Primary Outcomes
Depression response proportion
Time Frame: at 20th week
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
Secondary Outcomes
- Suicidality(at 20th week)
- Sleep quality(at 20th week)
- Quality of life(at 20th week)
- Depression remission proportion(at 20th week)
- Anxiety(at 20th week)
- Adverse events(at 4th 、8th、12th、16th、20th 、22th week)
- Seizure frequency(at 20th week)
- Seizure severity(at 20th week)