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Clinical Trials in Turkey / NCT07653009
Recruiting Not applicable

Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis

NCT07653009 · tracked via the Priya Life Science Turkey tracker
Sponsor
Marmara University
Phase
Not applicable
Started
2026-06-02
Last updated
2026-06-17

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Transcutaneous 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA) — Baseline, Day 10, and Month 3
    Disease activity will be assessed using the Disease Activity Index for Psoriatic Arthritis (DAPSA). Higher scores indicate greater disease activity and worse clinical status.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653009 on ClinicalTrials.gov ↗ ← All trials in Turkey