Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS).
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Disease Activity and Related Clinical Parameters in Patients With Psoriatic Arthritis
Overview
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
- 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 paramet
Primary outcome measures
- Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA) [Time frame: Baseline, Day 10, and Month 3]
Secondary outcome measures (12)
- Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: 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]
- Change in Pain Severity According to Visual Analog Scale (VAS) [Time frame: 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]
- Change in Disease Activity According to Physician Global Assessment (PGA) [Time frame: 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]
- Change in Quality of Life According to Short Form-12 Health Survey (SF-12) [Time frame: 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]
- Change in Autonomic Dysfunction Symptoms According to Composite Autonomic Symptom Score-31 (COMPASS-31) [Time frame: 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]
- Change in Fibromyalgia Symptoms According to Fibromyalgia Rapid Screening Tool (FiRST) [Time frame: Baseline, Day 10, and Month 3]
- Change in C-Reactive Protein (CRP) Level [Time frame: Baseline, Day 10, and Month 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Marmara University Pendik Training and Research Hospital — Istanbul
Publications
- Brock C, Rasmussen SE, Drewes AM, Moller HJ, Brock B, Deleuran B, Farmer AD, Pfeiffer-Jensen M. Vagal Nerve Stimulation-Modulation of the Anti-Inflammatory Response and Clinical Outcome in Psoriatic Arthritis or Ankylosing Spondylitis. Mediators Inflamm. 2021 May 27;2021:9933532. doi: 10.1155/2021/9933532. eCollection 2021. PMID 34135691
Identifiers
NCT: NCT07653009 · Marmara FTR ZMK 01