Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis

June 11, 2026 updated by: Marmara University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory disease characterized by heterogeneous clinical manifestations including peripheral arthritis, spondylitis, enthesitis, and dactylitis. Although currently available pharmacological therapies such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, and targeted synthetic DMARDs are effective in many patients, treatment response may vary, and long-term use may be associated with adverse effects, infection risk, high cost, and treatment resistance.

Recent neuroimmunology studies have demonstrated that the vagus nerve plays a significant role in modulation of inflammatory responses through the cholinergic anti-inflammatory pathway. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique targeting the auricular branch of the vagus nerve and has emerged as a potentially safe and reproducible therapeutic approach in inflammatory disorders.

Previous studies have shown that vagus nerve stimulation may reduce inflammatory cytokine production and improve clinical outcomes in diseases such as rheumatoid arthritis and systemic lupus erythematosus. However, evidence regarding the clinical and biological effects of taVNS in patients with psoriatic arthritis remains limited.

The aim of this prospective, single-center, single-arm interventional study is to evaluate the effects of taVNS on disease activity, pain, functional status, quality of life, autonomic dysfunction symptoms, sleep quality, anxiety/depression symptoms, and inflammatory biomarkers including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) in patients with PsA diagnosed according to the Classification Criteria for Psoriatic Arthritis (CASPAR).

Eligible participants aged 18-65 years with moderate-to-severe disease activity will undergo non-invasive auricular vagus nerve stimulation using the Vagustim device. Electrodes will be placed on the tragus and cymba conchae regions of the auricle, and electrical stimulation will be applied for 20 minutes per session according to predefined stimulation parameters.

Clinical assessments 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), Visual Analog Scale (VAS) pain scores, the Short Form-12 Health Survey (SF-12), Pittsburgh Sleep Quality Index (PSQI), Composite Autonomic Symptom Score-31 (COMPASS-31), Hospital Anxiety and Depression Scale (HADS), and Fibromyalgia Rapid Screening Tool (FiRST) will be evaluated before and after treatment.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara university pendik training and research hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: taVNS Group
Participants with psoriatic arthritis will receive transcutaneous auricular vagus nerve stimulation (taVNS) using the Vagustim device. Electrical stimulation will be applied through electrodes placed on the tragus and cymba conchae regions of the auricle for 20 minutes per session over a 10-day treatment period.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time Frame: 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.
Baseline, Day 10, and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline, Day 10, and Month 3
Disease activity and symptom severity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Scores range from 0 to 10, with higher scores indicating greater disease activity and symptom burden.
Baseline, Day 10, and Month 3
Change in Disease Activity According to Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP)
Time Frame: Baseline, Day 10, and Month 3
Disease activity will be evaluated using the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP). Higher scores indicate greater inflammatory disease activity and worse clinical status.
Baseline, Day 10, and Month 3
Change in Pain Severity According to Visual Analog Scale (VAS)
Time Frame: Baseline, Day 10, and Month 3
Pain severity will be assessed using the Visual Analog Scale (VAS), a validated self-reported measure in which participants rate their pain intensity on a scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Baseline, Day 10, and Month 3
Change in Global Disease Assessment According to Visual Analog Scale Global Assessment (VAS Global)
Time Frame: Baseline, Day 10, and Month 3
Participants' overall perception of disease activity will be assessed using the Visual Analog Scale Global Assessment (VAS Global), scored from 0 to 10. Higher scores indicate greater perceived disease activity and worse health status.
Baseline, Day 10, and Month 3
Change in Disease Activity According to Physician Global Assessment (PGA)
Time Frame: Baseline, Day 10, and Month 3
Overall disease activity will be evaluated using the Physician Global Assessment, scored from 0 to 10. Higher scores indicate greater disease activity and worse clinical status as assessed by the physician.
Baseline, Day 10, and Month 3
Change in Psoriasis Severity According to Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline, Day 10, and Month 3
Psoriasis severity and extent of skin involvement will be assessed using the Psoriasis Area and Severity Index (PASI). Scores range from 0 to 72, with higher scores indicating more severe psoriasis and greater skin involvement.
Baseline, Day 10, and Month 3
Change in Quality of Life According to Short Form-12 Health Survey (SF-12)
Time Frame: Baseline, Day 10, and Month 3
Health-related quality of life will be assessed using the Short Form-12 Health Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Baseline, Day 10, and Month 3
Change in Sleep Quality According to Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, Day 10, and Month 3
Sleep quality and sleep disturbances will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating poorer sleep quality and greater sleep disturbance.
Baseline, Day 10, and Month 3
Change in Autonomic Dysfunction Symptoms According to Composite Autonomic Symptom Score-31 (COMPASS-31)
Time Frame: Baseline, Day 10, and Month 3
Autonomic nervous system symptoms will be assessed using the Composite Autonomic Symptom Score-31 (COMPASS-31). Scores range from 0 to 100, with higher scores indicating greater autonomic symptom burden and worse autonomic dysfunction.
Baseline, Day 10, and Month 3
Change in Anxiety and Depression Symptoms According to Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, Day 10, and Month 3
Symptoms of anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Total scores range from 0 to 42, with higher scores indicating greater psychological distress.
Baseline, Day 10, and Month 3
Change in Fibromyalgia Symptoms According to Fibromyalgia Rapid Screening Tool (FiRST)
Time Frame: Baseline, Day 10, and Month 3
Fibromyalgia-related symptoms will be screened using the Fibromyalgia Rapid Screening Tool (FiRST). Scores range from 0 to 6, with higher scores indicating a greater likelihood of fibromyalgia.
Baseline, Day 10, and Month 3
Change in C-Reactive Protein (CRP) Level
Time Frame: Baseline, Day 10, and Month 3
Inflammatory activity will be evaluated by measuring serum C-reactive protein (CRP) levels. Higher values indicate greater systemic inflammation.
Baseline, Day 10, and Month 3
Achievement of Minimal Disease Activity (MDA)
Time Frame: Baseline, Day 10, and Month 3
Minimal Disease Activity (MDA) status will be assessed as a composite outcome according to established Psoriatic Arthritis Minimal Disease Activity criteria. Participants will be classified as achieving or not achieving MDA at each assessment time point.
Baseline, Day 10, and Month 3
Change in Functional Status According to Health Assessment Questionnaire (HAQ)
Time Frame: Baseline, Day 10, and Month 3
Functional disability and daily living activities will be evaluated using the Health Assessment Questionnaire (HAQ). Scores range from 0 to 3, with higher scores indicating greater functional impairment and disability.
Baseline, Day 10, and Month 3
Change in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline, Day 10, and Month 3
Inflammatory activity will be evaluated by measuring erythrocyte sedimentation rate (ESR). Higher values indicate greater systemic inflammation.
Baseline, Day 10, and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Halise Hande Gezer, MD, Associate Professor, Marmara University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

August 2, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Marmara FTR ZMK 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared. Aggregated results will be reported in publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe