NCT07293871

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Surf Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 weeks. This stage is designed to estimate the treatment effect size, using clinical and biomarker-based endpoints, and to collect safety and adherence data on a larger cohort. All participants will be followed through Week 12 to assess post-treatment safety and durability of clinical and immunologic effects.

Conditions

• Rheumatoid Arthritis (RA

Interventions

Type	Name	Description
DEVICE	Active treatment	Daily active ultrasound stimulation
DEVICE	Sham (No Treatment)	Daily sham ultrasound stimulation

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2025-12-19
• Last updated: 2026-01-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study