Daily at-home ultrasound to calm immune-driven joint inflammation 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
This study will test whether daily at-home ultrasound stimulation can reduce inflammation and improve symptoms in adults with moderate-to-high rheumatoid arthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Surf Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 2 sites (Colleyville, Texas and 1 other locations) |
| Trial ID | NCT07293871 on ClinicalTrials.gov |
What this trial studies
This Phase 2, two-stage multicenter study tests a daily at-home ultrasound device designed to trigger neuroimmune modulation in adults with rheumatoid arthritis. Stage 1 is an open-label pilot of 5–8 participants receiving active daily treatment for 8 weeks to confirm feasibility and safety. Stage 2 is a randomized, double-blind, sham-controlled phase enrolling up to 30 participants (2:1 active:sham) for 8 weeks to estimate treatment effect using clinical and biomarker endpoints. All participants are followed through Week 12 for post-treatment safety and durability of clinical and immunologic effects, and findings will inform design and power calculations for a future pivotal trial.
Who should consider this trial
Good fit: Adults (≥18) with ACR/EULAR-defined rheumatoid arthritis who have at least moderate disease activity, positive RF or anti-CCP, elevated hsCRP (≥10 mg/L), are on a stable DMARD regimen, and can comply with daily at-home device use.
Not a fit: Patients with mild disease activity or low CRP, those unable to use the device at home, those with recent medication changes, or those with multiple prior biologic failures for efficacy are less likely to benefit.
Why it matters
Potential benefit: If successful, this could offer a noninvasive, at-home treatment that lowers joint inflammation and symptoms and may reduce reliance on stronger drug therapies.
How similar studies have performed: Some neuromodulation approaches, including implanted and noninvasive vagus nerve stimulation, have shown promising early signals in RA, but daily at-home ultrasound neuromodulation is a novel approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Colleyville, Texas and 1 other locations
- Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, United States (Recruiting)
- Precision Comprehensive Clinical Research Solutions — Irving, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.