Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis
ConditionPsoriatic Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
DeviceNon-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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: taVNS GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA)
Disease activity will be assessed using the Disease Activity Index for Psoriatic Arthritis (DAPSA). Higher scores indicate greater disease activity and worse clinical status.
Time frame
Baseline, Day 10, and Month 3Secondary outcomes
1
Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Time frame
Baseline, Day 10, and Month 32
Change in Disease Activity According to Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP)
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.
Time frame
Baseline, Day 10, and Month 33
Change in Pain Severity According to Visual Analog Scale (VAS)
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).
Time frame
Baseline, Day 10, and Month 34
Change in Global Disease Assessment According to Visual Analog Scale Global Assessment (VAS Global)
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.
Time frame
Baseline, Day 10, and Month 3Sponsors and contacts
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Source ClinicalTrials.gov