TaVNS for Psoriatic Arthritis in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm interventional study evaluating transcutaneous auricular vagus nerve stimulation using the Vagustim device in adults with psoriatic arthritis. Participants meet CASPAR criteria, are 18 to 65, and have stable treatment plus moderate-to-high disease activity and significant pain. Outcomes include disease activity scores (DAPSA, ASDAS-CRP, BASDAI), pain, sleep, quality of life, anxiety/depression, and inflammatory biomarkers (CRP, ESR), assessed before and after taVNS treatment. The study aims to determine the potential clinical and biological effects of taVNS on PsA–related inflammation and symptoms. Prior evidence in other inflammatory diseases suggests possible anti-inflammatory benefits from vagus nerve stimulation, but data in psoriatic arthritis are limited.

Why it matters

Who can join: the full rules

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's running

• Marmara University Pendik Training and Research Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Halise Hande Gezer, MD, Associate Professor — Marmara University Faculty of Medicine
• Study coordinator: Zeynep M Kurt, MD
• Email: kurtzeynepmelis@gmail.com
• Phone: +90 533 485 59 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.