Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
NCT07293871 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-01-23
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.
Conditions
- Rheumatoid Arthritis (RA
Interventions
- DEVICE
-
Active treatment
Daily active ultrasound stimulation
- DEVICE
-
Sham (No Treatment)
Daily sham ultrasound stimulation
Sponsors & Collaborators
-
Surf Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-12-31
- Completion
- 2027-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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