Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

NCT ID
NCT07293871
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Surf Therapeutics
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial

Enrollment: 40 participants (Estimated).

What is being studied

  • Device: Active treatment
  • Device: Sham (No Treatment)

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * At least 18 years old * Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria * At least moderate disease activity, defined as ≥4 tender joints (28-joint count) and ≥4 swollen joints (28-joint count) and a DAS28-CRP \>3.2 at the baseline visit * hsCRP \> 0.3 mg/dL at the last qualifying visit, baseline or retest * If on background DMARD therapy, must be on stable dose (see exclusion criteria) * Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and assessments Exclusion Criteria: * Unable to provide informed consent * Current or planned participation in another interventional clinical trial * Inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis. Current diagnosis of secondary Sjogren's Syndrome is permitted. * Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy * Conventional synthetic DMARDs: * Initiation within 12 weeks prior to enrollment * Dose adjustment or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Biologic DMARDs: * Initiation or dose adjustment within 12 weeks prior to enrollment * Discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * JAK inhibitors: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Corticosteroids: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * Current dose \>10 mg/day prednisone (or equivalent) * If on a stable dose, inability to maintain the stable dose during the study * NSAIDs: * Initiation, dose adjustment, or discontinuation of high-dose NSAIDs (≥1200 mg/day ibuprofen) within 14 days of informed consent. Over-the-counter use of NSAIDs is permissible. * Pregnant or planning to become pregnant during the study period * Known hypersensitivity to ultrasound gel or membrane components * History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on baseline visit ultrasound * Rash, wound, or skin infection overlying the spleen * History of vagal nerve injury, vagotomy, or known autonomic neuropathy * Recent abdominal surgery or trauma within 30 days of screening * Skin to spleen hilum depth \>7 cm as measured by ultrasound at the baseline visit * Abdominal anatomy or condition precluding adequate ultrasound targeting of the spleen * Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting * Any condition that, in the investigator's judgment, would preclude safe participation or compliance with study procedures

Study locations

3 study locations are listed.

Recruiting site status is explicitly provided for 3 locations; 3 are listed as Recruiting.

Countries: United States

  • Texas, United States: 3

Sample of listed locations

  • Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, 75034, United States — Recruiting
  • Rheumatology Associates — Dallas, Texas, 75231, United States — Recruiting
  • Precision Comprehensive Clinical Research Solutions — Irving, Texas, 75061, United States — Recruiting

Study details

Start date
March 20, 2026
Primary completion date
January 1, 2027
Completion date
April 1, 2027
First posted
December 19, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07293871
Registry last updated
July 7, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07293871 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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