Psoriatic Arthritis
Conditions
Keywords
Transcutaneous Auricular Vagus Nerve Stimulation, Vagus Nerve Stimulation, Autonomic Dysfunction Disease Activity
Brief 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.
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.
Interventions
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.
Sponsors
Marmara University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-center, single-arm interventional study in which all eligible participants with psoriatic arthritis will receive transcutaneous auricular vagus nerve stimulation (taVNS) using the Vagustim device. Clinical and laboratory outcomes will be evaluated before and after the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 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. |
| Change in Disease Activity According to Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) | 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. |
| Change in Pain Severity According to Visual Analog Scale (VAS) | 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). |
| Change in Global Disease Assessment According to Visual Analog Scale Global Assessment (VAS Global) | 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. |
| Change in Disease Activity According to Physician Global Assessment (PGA) | 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. |
| Change in Psoriasis Severity According to Psoriasis Area and Severity Index (PASI) | 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. |
| Change in Quality of Life According to Short Form-12 Health Survey (SF-12) | 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. |
| Change in Sleep Quality According to Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Change in Autonomic Dysfunction Symptoms According to Composite Autonomic Symptom Score-31 (COMPASS-31) | 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. |
| Change in Anxiety and Depression Symptoms According to Hospital Anxiety and Depression Scale (HADS) | 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. |
| Change in Fibromyalgia Symptoms According to Fibromyalgia Rapid Screening Tool (FiRST) | 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. |
| Change in C-Reactive Protein (CRP) Level | 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. |
| Achievement of Minimal Disease Activity (MDA) | 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. |
| Change in Functional Status According to Health Assessment Questionnaire (HAQ) | 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. |
| Change in Erythrocyte Sedimentation Rate (ESR) | Baseline, Day 10, and Month 3 | Inflammatory activity will be evaluated by measuring erythrocyte sedimentation rate (ESR). Higher values indicate greater systemic inflammation. |
Countries
Turkey (Türkiye)
Contacts
CONTACTZeynep M Kurt, MD
PRINCIPAL_INVESTIGATORHalise Hande Gezer, MD, Associate Professor
Marmara University Faculty of Medicine
Outcome results
None listed