Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

Summary

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.

Eligibility

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

Conditions2

Locations2 sites

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