Tests ultrasound stimulation of the spleen in rheumatoid arthritis
Tests spleen ultrasound stimulation against a sham in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
Key facts
- Where
- Colleyville, Dallas, and Irving, United StatesSee the 3 sites
Where in United States
- Precision Comprehensive Clinical Research SolutionsColleyville, United StatesTaking people
- Rheumatology AssociatesDallas, United StatesTaking people
- Precision Comprehensive Clinical Research SolutionsIrving, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Surf Therapeutics
- Trial code
- NCT07293871
- Record updated
- 7 July 2026
- Original description
This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of splenic ultrasound stimulation to activate immune-neuromodulation (SUSTAIN) in patients with rheumatoid arthritis (RA) and at least moderate disease activity. 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.Read full original descriptionShow less
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of splenic ultrasound stimulation to activate immune-neuromodulation (SUSTAIN) in patients with rheumatoid arthritis (RA) and at least moderate disease activity. 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.
Inclusion: 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: 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; Recent abdominal surgery or trauma within 30 days of screening; 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; 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; 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; Unable to provide informed consent; Current or planned participation in another interventional clinical trial; 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; Skin to spleen hilum depth >7 cm as measured by ultrasound at the baseline visit.