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Ultrasound Neuroimmune Modulation for Rheumatoid Arthritis

This study is testing a new approach called daily active ultrasound stimulation to help adults with rheumatoid arthritis (RA). RA is a condition where your body's immune system attacks your joints, causing pain and swelling. The study aims to see if this ultrasound stimulation is safe and if it shows early signs of helping to reduce RA symptoms. You might be able to join if you are at least 18 years old, have been diagnosed with RA, and have at least moderate disease activity (meaning a certain number of tender and swollen joints, and a specific blood test result called DAS28-CRP and hsCRP). The main goals are to track any side effects and how well people stick to the treatment over 8 to 12 weeks. The study is currently in an unclear status regarding recruitment.

Study design
This is a two-stage study, starting with an open-label pilot study of 6-10 participants. This means everyone in the first stage knows they are receiving the active ultrasound treatment.
What's involved
You would receive daily active ultrasound stimulation for 8 weeks. Your health would be monitored for adverse events for 12 weeks, and adherence to therapy would be measured at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for adverse events for 12 weeks after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07293871

Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

Recruiting
NAAges 18+InterventionalTreatment
Surf Therapeutics
~40 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Active treatmentSham (No Treatment)

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over 12 weeks
+1 more outcome measured

Conditions

Rheumatoid Arthritis

Explore related trials

Rheumatoid Arthritis

Where it's being run

3 sites across 1 states
Texas3

Who to contact

Alexander Sackeim, MD
[email protected]
9145237345
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

Exclusion

Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and assessments
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

What this trial measures

  • Incidence of Adverse Events12 weeks

    All adverse events (AEs) regardless of treatment group that occur over the 12 week enrollment period will be coded and summarized by frequency, severity, and relatedness using the latest MedDRA version (v28.1).

  • Adherence to Therapy8 weeks

    Proportion of patients adherent to treatment, defined by completing ≥70% of the 56 scheduled ultrasound treatments