NCT07403890

Brief Summary

Despite advances in immunomodulatory therapies, many Psoriatic arthritis (PsA) patients experience persistent pain unrelated to clinical active joint inflammation. Recent evidence suggests the Inferior Parietal Lobule (IPL) serves as a neuroimmune hub linking central neural activity with peripheral immune dysregulation. In a prior feasibility study, a single L-IPL-targeted TMS session reduced pain and altered immune signalling in inflammatory arthritis by reducing STAT3 phosphorylation in circulating monocytes. This study builds on those findings by evaluating whether rTMS over 4 weeks can induce sustained immune reprogramming while providing meaningful pain relief.

Trial Health

63
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

January 16, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2028

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

January 16, 2026

Last Update Submit

February 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in STAT3 phosphorylation in circulating monocytes

    Assessment of the effect of left-inferior parietal lobule (L-IPL) targeted repetitive transcranial magnetic stimulation (rTMS) on immune systems; specifically changes in circulating monocytes intracellular signalling, primarily STAT3 phosphorylation levels, assessed via flow cytometry, before and after rTMS targeting L-IPL compared with the control (vertex stimulation) condition.

    Week 1 to Week 4

Secondary Outcomes (13)

  • Changes in genetic expression of circulating immune cells, monocytes and CD8+ T-cells, using transcriptomic assays (RNA-seq).

    Week 1 to Week 4

  • Changes in trained immunity set-points in monocytes and CD8+ T-cells, by investigating their epigenetic profile changes using Cleavage Under Targets and Tagmentation (CUT&TAG assay).

    Week 1 to Week 4

  • Changes in pain severity as measured by the Pain Number Rating Scale.

    Week 1 to Week 4

  • Changes in pain severity as measured by Widespread Pain as part of the American College of Rheumatology Fibromyalgia scale.

    Week 1 to Week 4

  • Changes in putative pain confounders as measured by PROMIS-Fatigue.

    Week 1 to Week 4

  • +8 more secondary outcomes

Other Outcomes (7)

  • Feasibility data on EQ-5D quality of life scores.

    Week 1 and Week 4

  • Feasibility data on participant adherence.

    Week 0 to Week 4

  • Feasibility data on TMS tolerability.

    Week 1 to Week 4

  • +4 more other outcomes

Study Arms (2)

rTMS (Left Inferior Parietal Lobule)

EXPERIMENTAL

Participants receive active repetitive transcranial magnetic stimulation (rTMS) targeted to the left inferior parietal lobule (L-IPL). Stimulation is delivered at 10 Hz, 90% resting motor threshold, 1200 pulses per session, across 12 sessions over 4 weeks. This arm is designed to evaluate whether neuromodulation of the L-IPL alters immune signalling and reduces persistent pain in psoriatic arthritis.

Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS (Vertex Stimulation)

SHAM COMPARATOR

Participants receive control rTMS delivered to the cranial vertex, a site not expected to modulate neuroimmune pathways relevant to pain. Stimulation parameters match the active arm (10 Hz, 90% resting motor threshold, 1200 pulses per session, 12 sessions over 4 weeks). This arm controls for nonspecific effects of rTMS, including sensory experience and participant expectations.

Device: Control Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

rTMS delivered to the left inferior parietal lobule at 10 Hz, 90% resting motor threshold, 1200 pulses per session, for 12 sessions over 4 weeks.

rTMS (Left Inferior Parietal Lobule)

rTMS delivered to the cranial vertex using identical stimulation parameters to the active arm, serving as a control condition.

rTMS (Vertex Stimulation)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years ≤ 75 years
  • Diagnosis of PsA according to CASPAR (Classification Criteria for Psoriatic Arthritis).
  • Low disease activity (no more than one joint with clinically active swelling) or remission
  • Chronic pain for at least 3 months and VAS (Visual Analogue Scale) pain ≥30 mm
  • Stable treatment ≥3 months prior to entering the study
  • Able and willing to maintain medication for the duration study
  • Able to undergo MRI and TMS procedures

You may not qualify if:

  • Inability to provide written informed consent.
  • Severe physical impairment (e.g. blindness, deafness, paraplegia) Pregnant, planning pregnancy or breast feeding.
  • Severe claustrophobia precluding MRI.
  • Contraindications to MRI (e.g. metal implants/ pacemaker).
  • Contraindications to TMS (e.g. history of seizures).
  • Serious infection including sepsis, tuberculosis and opportunistic infections such as invasive fungal infections.
  • Major confounding neurological disease including Multiple
  • Sclerosis, Stroke, Traumatic Brain Injury, Parkinson's Disease, Alzheimer's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Flavia Sunzini, MD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Basu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are masked to group allocation. The rTMS operator is not masked due to the need to position the coil at different stimulation sites.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are randomised 1:1 to receive either active rTMS to the left inferior parietal lobule or control rTMS to the vertex for 12 sessions over 4 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

February 11, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 28, 2028

Study Completion (Estimated)

March 28, 2028

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations