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Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will receive daily active SUSTAIN therapy for 8 weeks."
  • "The initial active ultrasound parameter set (Experimental Treatment 1) will be based on the best available evidence at the start of the trial."
  • "Stage 2 consists of a double-blind, randomized, sham-controlled study enrolling 30-40 participants, randomized 1:1 to receive daily active or sham SUSTAIN therapy for 8 weeks."
  • "Selection of the Stage 2 active treatment ultrasound parameter set will be based on the safety profile and magnitude/direction of the DAS28-CRP change from Baseline to Week 4 of the two experimental treatments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ultrasound treatment aimed at the spleen, an organ that helps fight infection, in adults with rheumatoid arthritis and at least moderate symptoms. It checks whether the treatment is practical, safe, and may help by using nerve signals to affect the immune system.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have rheumatoid arthritis diagnosed using the study’s required standards.
  • At the first study visit, you have at least 4 tender and 4 swollen joints among the 28 joints checked, plus a disease activity score above 3.2.
  • Your hsCRP blood test, which measures inflammation, is above 0.3 mg/dL at the last qualifying test.
  • If you take DMARDs, medicines that slow arthritis, your dose must be stable.
  • You can and will attend daily treatments in the study vehicle, study visits, and tests.

Who can't join

  • You cannot give informed consent, or you are in or plan to join another study that tests a treatment.
  • You have another inflammatory joint disease. Secondary Sjogren’s syndrome is allowed. Uncontrolled fibromyalgia or other widespread pain that could affect symptom reports may also rule you out.
  • You stopped more than 2 biologic or targeted synthetic arthritis medicines mainly because they did not work well enough.
  • You recently started, changed, or stopped arthritis medicines or steroids within the study’s limits of 4–12 weeks; cannot keep required doses stable; or take more than 10 mg of prednisone daily or an equal dose of another steroid.
  • You started, changed, or stopped high-dose anti-inflammatory pain medicine within 14 days before consent, such as ibuprofen at 1,200 mg daily or more. Over-the-counter use is allowed.
  • You are pregnant or plan to become pregnant during the study, or you are allergic to the ultrasound gel or membrane materials.
  • You have a spleen disorder, a missing or enlarged spleen, or a rash, wound, or skin infection over it. You also cannot join if the ultrasound target is more than 7 cm below the skin or your belly’s shape or condition prevents treatment.
  • You have damage to the vagus nerve, surgery that cut it, or damage to nerves that control automatic body functions; had belly surgery or injury within 30 days of screening; or have another condition the study doctor believes makes participation unsafe or prevents following study steps.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (3)

TX