Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study] (ULTRA)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    15
  • sponsor
    SecondWave Systems Inc.
Updated on 4 October 2022
synovitis
erythrocyte sedimentation

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 clinical metrics during and after an 8-week course of spleen-directed daily ultrasound treatments.
  • Measure molecular correlates, including Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), cortisol and cytokine levels, of rheumatoid arthritis disease activity during spleen-directed daily ultrasound treatments.

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 to treat inflammatory diseases including Rheumatoid Arthritis.

Multiple studies in animals with hyper-inflammation conditions (e.g., inflammatory arthritis and sepsis/lipopolysaccharide [LPS] injections) and recent human studies (e.g., for the treatment of joint inflammation in Rheumatoid Arthritis) have shown that ultrasound applied to the spleen can suppress blood/genetic markers of inflammation.

This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI ultrasound system.

This is a pilot single-arm treatment trial in which up to 15 study participants will receive noninvasive splenic-ultrasound therapy over eight weeks (five daily stimulation sessions per week). Clinical outcomes will be compared from baseline to end of the 8-week treatment period. Investigational splenic-ultrasound therapy will be delivered with the SecondWave MINI ultrasound system. The objective of the study is to assess the safety and potential efficacy for the MINI system for treatment of Rheumatoid Arthritis.

For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. Study personnel will use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area. Daily stimulation consists of an approximately 18-minute period for application of ultrasound to the spleen. Collection of clinical outcome data, patient-reported assessments, and blood draws collected at the 5 study visits to assess biomarkers of inflammation will be performed in each participant throughout the study.

Details
Condition Rheumatoid Arthritis
Treatment Splenic Ultrasound
Clinical Study IdentifierNCT05417854
SponsorSecondWave Systems Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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