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

Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis (NCT07293871) is a Phase 2 interventional studying Rheumatoid Arthritis (RA, sponsored by Surf Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rheumatoid Arthritis (RA and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - At least 18 years old - Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria - A positive test result for Rheumatoid Factor (RF) \> 14 IU/mL and/or Anti-Citrullinated Protein Antibodies (Anti-CCP) ≥ 20 U/mL - At least moderate disease activity, defined as DAS28-CRP \> 3.8 and at least 4/28 tender and 4/28 swollen joints at the screening and baseline visits - High sensitivity CRP (hsCRP) ≥ 10 mg/L at the screening and baseline visits - On stable dose of background DMARD therapy (see exclusion criteria) - Able and willing to comply with all study-related procedures, including at-home device use, daily treatment, scheduled visits, and assessments Who Should NOT Join This Trial: - Unable to provide willing to sign a consent form - Current or planned participation in another interventional clinical trial - Prior use of \> 2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy - Conventional synthetic DMARDs: - Initiated within last 12 weeks or adjusted dose within 4 weeks prior to enrollment - Inability to maintain a stable dose during the study - Biologic DMARDs: - Initiated or dose-adjusted within 12 weeks prior to enrollment - Inability to maintain a stable dose during the study - JAK inhibitors: - Use within 4 weeks prior to enrollment or expected use during study participation - Corticosteroids: - Initiated or dose-adjusted within 4 weeks prior to enrollment - Current dose \> 10 mg/day prednisone (or equivalent) - Current tobacco or nicotine product use - Pregnant or planning to become pregnant during the study period - Known hypersensitivity to ultrasound gel or membrane components - Active bacterial, viral, or fungal infection - Receiving chemotherapy or immunotherapy for malignancy - History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on screening ultrasound - Rash, wound, or skin infection overlying the spleen ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * At least 18 years old * Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria * A positive test result for Rheumatoid Factor (RF) \> 14 IU/mL and/or Anti-Citrullinated Protein Antibodies (Anti-CCP) ≥ 20 U/mL * At least moderate disease activity, defined as DAS28-CRP \> 3.8 and at least 4/28 tender and 4/28 swollen joints at the screening and baseline visits * High sensitivity CRP (hsCRP) ≥ 10 mg/L at the screening and baseline visits * On stable dose of background DMARD therapy (see exclusion criteria) * Able and willing to comply with all study-related procedures, including at-home device use, daily treatment, scheduled visits, and assessments Exclusion Criteria: * Unable to provide informed consent * Current or planned participation in another interventional clinical trial * Prior use of \> 2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy * Conventional synthetic DMARDs: * Initiated within last 12 weeks or adjusted dose within 4 weeks prior to enrollment * Inability to maintain a stable dose during the study * Biologic DMARDs: * Initiated or dose-adjusted within 12 weeks prior to enrollment * Inability to maintain a stable dose during the study * JAK inhibitors: * Use within 4 weeks prior to enrollment or expected use during study participation * Corticosteroids: * Initiated or dose-adjusted within 4 weeks prior to enrollment * Current dose \> 10 mg/day prednisone (or equivalent) * Current tobacco or nicotine product use * Pregnant or planning to become pregnant during the study period * Known hypersensitivity to ultrasound gel or membrane components * Active bacterial, viral, or fungal infection * Receiving chemotherapy or immunotherapy for malignancy * History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on screening 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 * Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting

Treatments Being Tested

DEVICE

Active treatment

Daily active ultrasound stimulation

DEVICE

Sham (No Treatment)

Daily sham ultrasound stimulation

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Precision Comprehensive Clinical Research Solutions

Irving, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07293871), the sponsor (Surf Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07293871 clinical trial studying?

Who can participate in NCT07293871?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07293871?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07293871. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07293871. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.