Status:
COMPLETED
Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study]
Lead Sponsor:
SecondWave Systems Inc.
Collaborating Sponsors:
University of Minnesota
DARPA (United States Department of Defense)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The research objective is to assess efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a pilot study. Specific Aims: * Measure RA disease activity and clinica...
Detailed Description
Ultrasound is widely used in human medicine because it is safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able...
Eligibility Criteria
Inclusion
- Males and females ages 18 and above
- Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010\_revised\_criteria\_classification\_ra.pdf)
- \- Classification as "definite RA" is based on the confirmed presence of synovial thickening in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1)
- Exhibiting symptoms or signs of inadequate inflammatory disease control according to one of two measures:
- Multidimensional HAQ score of greater than 0.3
- DAS-28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease\_Activity\_Score\_-\_CRP\_(DAS-CRP)
- Candidate participant's rheumatoid arthritis medical therapy should be stable for two weeks leading up to the study. Moreover, participants must be willing to maintain their current medication regimen throughout the study enrollment period (in adjunct to the additional investigational ultrasound treatment)
Exclusion
- Active bacterial or viral infection
- Pregnant women or those trying to become pregnant
- Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
- Having received Rituximab monoclonal antibody medication within 30 days prior to enrollment
- Presence of an implanted device
- Asplenia
- Splenomegaly
- Ascites
- Recent abdominal surgery
- Currently participating in an investigational drug or device study
- Open wound/sores near stimulation sites
- Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05417854
Start Date
June 29 2022
End Date
September 25 2023
Last Update
October 12 2023
Active Locations (2)
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1
University of Minnesota - Phillips-Wangensteen Building
Minneapolis, Minnesota, United States, 55455
2
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, United States, 55455