RecruitingNot ApplicableNCT07653009

Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis

The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Disease Activity and Related Clinical Parameters in Patients With Psoriatic Arthritis

Sponsor

Marmara University

Enrollment

15 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Psoriatic Arthritis

Summary

This prospective single-center interventional study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on disease activity, pain, quality of life, autonomic dysfunction symptoms, and inflammatory biomarkers in patients with psoriatic arthritis (PsA). Participants diagnosed with PsA according to the Classification Criteria for Psoriatic Arthritis (CASPAR) will undergo non-invasive auricular vagus nerve stimulation using the Vagustim device. Clinical outcomes including the Disease Activity Index for Psoriatic Arthritis (DAPSA), Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain scores, sleep quality, quality of life, anxiety/depression, and inflammatory markers including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) will be evaluated before and after treatment.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

Diagnosis of psoriatic arthritis according to the CASPAR criteria
Age between 18 and 65 years
Stable treatment regimen for at least 12 weeks prior to enrollment
Visual Analog Scale (VAS) pain score ≥4 on a 0-10 scale
Moderate-to-high disease activity according to the Disease Activity Index for Psoriatic Arthritis (DAPSA)
Ability and willingness to provide written informed consent

Exclusion Criteria6

Presence of an implanted cardiac device (e.g., pacemaker, implantable cardioverter-defibrillator) or implanted neurostimulator
History of epilepsy or other uncontrolled neurological disorders
Active severe infection or immunosuppressive condition (e.g., sepsis)
Pregnancy or breastfeeding
Presence of deep auricular injury, previous ear surgery, or active skin lesions involving the auricle
Inability to comply with the treatment protocol or history of severe psychiatric disorders

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscutaneous Auricular Vagus Nerve Stimulation (taVNS)

Non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) will be administered using the Vagustim device. Electrodes will be placed on the tragus and cymba conchae regions of the auricle, which are anatomically associated with the auricular branch of the vagus nerve. Electrical stimulation will be applied for 20 minutes per session over a 10-day treatment period while participants are in a seated position. All procedures will be performed according to standardized stimulation parameters and patient safety protocols.