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Psoriatic ArthritisNCT07653009

Transcutaneous Auricular Vagus Nerve Stimulation in Psoriatic Arthritis

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Psoriatic Arthritis, run by Marmara University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Jun 2026to 2 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Disease Activity and Related Clinical Parameters in Patients With Psoriatic Arthritis

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.

Read the 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.

Being tested
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Keywords
Transcutaneous Auricular Vagus Nerve Stimulation, Vagus Nerve Stimulation, Autonomic Dysfunction Disease Activity
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device

    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.

Study groups in NCT07653009
Study groupRoleWhat they receive
taVNS GroupExperimentalParticipants 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.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Day 10, and Month 3

Secondary outcomes (15)
  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.

    Measured: Baseline, Day 10, and Month 3

  2. 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.

    Measured: Baseline, Day 10, and Month 3

  3. 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).

    Measured: Baseline, Day 10, and Month 3

  4. 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.

    Measured: Baseline, Day 10, and Month 3

  5. Change in Disease Activity According to Physician Global Assessment (PGA)

    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.

    Measured: Baseline, Day 10, and Month 3

  6. Change in Psoriasis Severity According to Psoriasis Area and Severity Index (PASI)

    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.

    Measured: Baseline, Day 10, and Month 3

  7. Change in Quality of Life According to Short Form-12 Health Survey (SF-12)

    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.

    Measured: Baseline, Day 10, and Month 3

  8. Change in Sleep Quality According to Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: Baseline, Day 10, and Month 3

  9. Change in Autonomic Dysfunction Symptoms According to Composite Autonomic Symptom Score-31 (COMPASS-31)

    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.

    Measured: Baseline, Day 10, and Month 3

  10. Change in Anxiety and Depression Symptoms According to Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: Baseline, Day 10, and Month 3

  11. Change in Fibromyalgia Symptoms According to Fibromyalgia Rapid Screening Tool (FiRST)

    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.

    Measured: Baseline, Day 10, and Month 3

  12. Change in C-Reactive Protein (CRP) Level

    Inflammatory activity will be evaluated by measuring serum C-reactive protein (CRP) levels. Higher values indicate greater systemic inflammation.

    Measured: Baseline, Day 10, and Month 3

  13. Achievement of Minimal Disease Activity (MDA)

    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.

    Measured: Baseline, Day 10, and Month 3

  14. Change in Functional Status According to Health Assessment Questionnaire (HAQ)

    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.

    Measured: Baseline, Day 10, and Month 3

  15. Change in Erythrocyte Sedimentation Rate (ESR)

    Inflammatory activity will be evaluated by measuring erythrocyte sedimentation rate (ESR). Higher values indicate greater systemic inflammation.

    Measured: Baseline, Day 10, and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start2 Jun 2026
  3. Primary completion2 Jun 2027 (estimated)
  4. Study completion2 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653009
Sponsor's protocol ID
Marmara FTR ZMK 01
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be shared. Aggregated results will be reported in publications.

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.

    PubMed 34135691

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Psoriatic Arthritis, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zeynep M Kurt, MD (+90 533 485 59 11, kurtzeynepmelis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Disease Activity According to Disease Activity Index for Psoriatic Arthritis (DAPSA) (time frame: Baseline, Day 10, and Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07653009, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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