Ultrasound Treatment of Rheumatoid Arthritis

Study Overview
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Brief Summary
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The research objective of the pilot study is to assess early feasibility of safety and efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a blinded and randomized controlled trial. Specific Aims include: Measure RA disease activity and functional/biomarker metrics during and after a 2- week course of spleen-directed daily ultrasound treatments (within-arm and between-arm assessments); and Monitor adverse events during and after daily ultrasound treatments.

Official Title
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Ultrasound Treatment of Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Study device treatment
* Device: Sham device treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females aged 18 and over. 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 synovitis in at least one 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 disease control according to one of 2 measures: Modified HAQ score of greater than 0.3 and DAS28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease_Activity_Score_-_CRP_(DAS-CRP). Participants should have home access to broadband internet, such that online video conversations can occur with study personnel via study-provided personal digital assistive devices. Exclusion Criteria: Active bacterial or viral infection. Pregnant women or presence of active malignancy. Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a controlled, randomized, double-blinded trial of short-term (14 days) treatment with ultrasound stimulation (therapeutic energy dose) or sham (no energy dose) delivered to the spleen. Participants will be provided a portable ultrasound device or sham device for at home use. Participants will be trained on how to use the device and will be instructed to use it for 30 minutes per day, at approximately the same time each day for 14 days. Participants will be assessed at several time points before, during and at the end of treatment as well as a one-week follow-up visit.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study device treatment<br>Transcutaneous non-invasive ultrasound will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device. | Device: Study device treatment<br>* The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.<br>* Other names: Treatment group;|
| Sham Comparator: Sham device treatment<br>Sham treatment will be administered to the spleen for 30 minutes every day for 2 weeks (14 days total) via a portable device. | Device: Sham device treatment<br>* A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-arm change in the Disease Activity Score (DAS-28) from baseline to end of treatment for treatment group. | Full p-value of 0.05 will be allocated to Primary Outcome Measure and then if outcome is satisfied, the full p-value of 0.05 will be allocated to Secondary Outcome Measure. | Day 0 (baseline) to Day 14 (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-arm change in the DAS-28 from baseline to end of treatment. | Full p-value of 0.05 will be allocated to Primary Outcome Measure and then if outcome is satisfied, the full p-value of 0.05 will be allocated to Secondary Outcome Measure. | Day 0 (baseline) to Day 14 (end of treatment) |