Actively Recruiting
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
Led by Surf Therapeutics · Updated on 2026-01-23
40
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of at-home ultrasound stimulation to activate immune-neuromodulation in patients with rheumatoid arthritis (RA) and at least moderate disease activity. The study will enroll up to 40 participants at up to 6 sites across 2 stages. The findings from this trial will directly inform the design and power calculations for a future pivotal trial by identifying an appropriate effect size and confirming protocol feasibility and safety for a daily home-use therapy.
CONDITIONS
Official Title
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria
- Positive test for Rheumatoid Factor > 14 IU/mL and/or Anti-Citrullinated Protein Antibodies 20 U/mL
- At least moderate disease activity with DAS28-CRP > 3.8 and at least 4 tender and 4 swollen joints at screening and baseline
- High sensitivity CRP (hsCRP) 2 10 mg/L at screening and baseline
- On a stable dose of background DMARD therapy
- Able and willing to comply with all study procedures including daily at-home device use and scheduled visits
You will not qualify if you...
- Unable to provide informed consent
- Current or planned participation in another interventional clinical trial
- Prior use of more than 2 biologic or targeted synthetic DMARDs for RA discontinued primarily for efficacy reasons
- Initiation or dose adjustment of conventional synthetic DMARDs within 12 weeks or 4 weeks prior to enrollment, or inability to maintain stable dose during study
- Initiation or dose adjustment of biologic DMARDs within 12 weeks prior to enrollment, or inability to maintain stable dose during study
- Use of JAK inhibitors within 4 weeks prior to enrollment or expected use during study
- Initiation or dose adjustment of corticosteroids within 4 weeks prior to enrollment or current dose above 10 mg/day prednisone or equivalent
- Current use of tobacco or nicotine products
- Pregnant or planning pregnancy during study
- Known allergy to ultrasound gel or membrane components
- Active bacterial, viral, or fungal infection
- Receiving chemotherapy or immunotherapy for cancer
- History of splenic disorders or splenectomy
- Rash, wound, or skin infection overlying spleen
- History of vagal nerve injury, vagotomy, or autonomic neuropathy
- Recent abdominal surgery or trauma within 30 days of screening
- Uncontrolled fibromyalgia or other diffuse pain syndromes that could affect symptom reporting
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States, 75034
Actively Recruiting
2
Precision Comprehensive Clinical Research Solutions
Irving, Texas, United States, 75061
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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