Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis
The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Disease Activity and Related Clinical Parameters in Patients With Psoriatic Arthritis
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Zeynep M Kurt, MD
- 电话号码：+90 533 485 59 11
- 邮箱：kurtzeynepmelis@gmail.com
学习地点
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Istanbul、土耳其（türkiye）、34899
- 招聘中
- Marmara University Pendik Training and Research Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA)
大体时间：Baseline, Day 10, and Month 3
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Disease activity will be assessed using the Disease Activity Index for Psoriatic Arthritis (DAPSA).
Higher scores indicate greater disease activity and worse clinical status.
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Baseline, Day 10, and Month 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Disease Activity According to Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Pain Severity According to Visual Analog Scale (VAS)
大体时间：Baseline, Day 10, and Month 3
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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).
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Baseline, Day 10, and Month 3
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Change in Global Disease Assessment According to Visual Analog Scale Global Assessment (VAS Global)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Disease Activity According to Physician Global Assessment (PGA)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Psoriasis Severity According to Psoriasis Area and Severity Index (PASI)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Quality of Life According to Short Form-12 Health Survey (SF-12)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Sleep Quality According to Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Autonomic Dysfunction Symptoms According to Composite Autonomic Symptom Score-31 (COMPASS-31)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Anxiety and Depression Symptoms According to Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Fibromyalgia Symptoms According to Fibromyalgia Rapid Screening Tool (FiRST)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in C-Reactive Protein (CRP) Level
大体时间：Baseline, Day 10, and Month 3
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Inflammatory activity will be evaluated by measuring serum C-reactive protein (CRP) levels.
Higher values indicate greater systemic inflammation.
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Baseline, Day 10, and Month 3
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Achievement of Minimal Disease Activity (MDA)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Functional Status According to Health Assessment Questionnaire (HAQ)
大体时间：Baseline, Day 10, and Month 3
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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.
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Baseline, Day 10, and Month 3
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Change in Erythrocyte Sedimentation Rate (ESR)
大体时间：Baseline, Day 10, and Month 3
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Inflammatory activity will be evaluated by measuring erythrocyte sedimentation rate (ESR).
Higher values indicate greater systemic inflammation.
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Baseline, Day 10, and Month 3
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合作者和调查者
调查人员
- 首席研究员：Halise Hande Gezer, MD, Associate Professor、Marmara University Faculty of Medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Marmara FTR ZMK 01
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