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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Zeynep M Kurt, MD
- Telefonnummer: +90 533 485 59 11
- E-post: kurtzeynepmelis@gmail.com
Studiesteder
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Istanbul, Tyrkia (Türkiye), 34899
- Rekruttering
- Marmara University Pendik Training and Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Halise Hande Gezer, MD, Associate Professor, Marmara University Faculty of Medicine
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- Marmara FTR ZMK 01
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