NCT07653009

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

June 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2027

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 11, 2026

Conditions

Psoriatic Arthritis

Keywords

Transcutaneous Auricular Vagus Nerve StimulationVagus Nerve StimulationAutonomic Dysfunction Disease Activity

Outcome Measures

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.

    Baseline, Day 10, and Month 3

Secondary Outcomes (15)

  • Change in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Baseline, Day 10, and Month 3

  • Change in Disease Activity According to Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP)

    Baseline, Day 10, and Month 3

  • Change in Pain Severity According to Visual Analog Scale (VAS)

    Baseline, Day 10, and Month 3

  • Change in Global Disease Assessment According to Visual Analog Scale Global Assessment (VAS Global)

    Baseline, Day 10, and Month 3

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

    Baseline, Day 10, and Month 3

  • +10 more secondary outcomes

Study Arms (1)

taVNS Group

EXPERIMENTAL

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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interventions

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.

taVNS Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 34135691RESULT

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Halise Hande Gezer, MD, Associate Professor

    Marmara University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep M Kurt, MD

CONTACT

+90 533 485 59 11kurtzeynepmelis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 17, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

August 2, 2027

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared. Aggregated results will be reported in publications.

Locations

TU(1)