At-home Ultrasound Therapy for Rheumatoid Arthritis (At-home ULTRA Study)

This study is looking into a new way to treat moderate to severe rheumatoid arthritis (RA) using a device that delivers ultrasound stimulation to the spleen. The goal is to see if this non-invasive (no needles or surgery) treatment can help reduce inflammation. You would continue taking your current conventional synthetic DMARD (disease-modifying anti-rheumatic drug) throughout the study. There are two groups receiving different settings of the ultrasound stimulation and one group receiving a sham (inactive) stimulation. Researchers will compare how well the active treatments work against the sham treatment by measuring changes in your RA symptoms over 12 weeks. The study plans to include at least 60 participants.

Study design
This interventional study will enroll at least 60 participants and has three groups: two receiving active ultrasound stimulation and one receiving sham (inactive) stimulation. All participants will also be taking a conventional synthetic DMARD.
What's involved
You would receive daily non-invasive ultrasound stimulation of the spleen for 20 minutes once per day. You would also continue taking your conventional synthetic DMARD at a stable dose throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for the study will be taken at 12 weeks after starting the treatment period.

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NCT07163221

At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]

Recruiting
NAAges 18+InterventionalTreatment
SecondWave Systems Inc.
~60 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2Sham ultrasound stimulation (control)Conventional Synthetic DMARD

At a glance

Recruiting sites
1 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)
Measured over 12 weeks
+1 more outcome measured
Rheumatoid Arthritis (RA)
5 sites across 4 states
California2
Arizona1
Colorado1
Minnesota1
  • Daniel Zachs · STUDY_DIRECTOR · SecondWave Systems Inc.

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  • Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)12 weeks

    A decrease in Disease Activity Score indicates an improved outcome

  • Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)12 weeks

    A decrease in Disease Activity Score indicates an improved outcome