RecruitingPhase 2NCT07293871

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


Sponsor

Surf Therapeutics

Enrollment

40 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether focused ultrasound applied to the spleen — a non-invasive technique that stimulates immune-regulating nerve pathways — can reduce inflammation and improve symptoms in people with active rheumatoid arthritis who are already on disease-modifying drugs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rheumatoid arthritis by standard criteria - You have a positive test for rheumatoid factor (RF) or anti-CCP antibodies - Your disease is at least moderately active (DAS28-CRP score above 3.8, with 4 or more tender and 4 or more swollen joints) - Your inflammation marker (CRP) is elevated (10 mg/L or higher) - You are on a stable dose of disease-modifying medication **You may NOT be eligible if...** - You are unable to provide consent - You have a condition preventing at-home device use or scheduled clinic visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive treatment

Daily active ultrasound stimulation

DEVICESham (No Treatment)

Daily sham ultrasound stimulation


Locations(2)

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Precision Comprehensive Clinical Research Solutions

Irving, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07293871


Related Trials