Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
Surf Therapeutics
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.
Description
Stage 1 is an open-label pilot study of 5-8 participants receiving active daily ultrasound stimulation for 8 weeks. The primary objective is to assess feasibility and safety, defined by the absence of device-related serious adverse events (SAEs) or Grade ≥2 adverse events (AEs) requiring medical intervention per CTCAE criteria. Data from Stage 1 will be used to refine trial procedures and confirm readiness for Stage 2. Stage 2 consists of a randomized double-blind, sham-controlled study enrolling up to 30 participants, allocated 2:1 to receive active or sham daily ultrasound stimulation for 8…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 al…
Interventions
- DeviceActive treatment
Daily active ultrasound stimulation
- DeviceSham (No Treatment)
Daily sham ultrasound stimulation
Locations (2)
- Precision Comprehensive Clinical Research SolutionsColleyville, Texas
- Precision Comprehensive Clinical Research SolutionsIrving, Texas