Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis
Recruiting · NCT07653009 · Interventional (participants receive a specific treatment) · Lead sponsor: Marmara University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Marmara University Pendik Training and Research Hospital - Istanbul, Turkey (Türkiye)