Splenic Ultrasound for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Minnesota Health Clinics and Surgery Center, Minneapolis, MN
Rheumatoid Arthritis+2 More
Splenic Ultrasound - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Rheumatoid Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: End of study participation

8 weeks
Within-arm change in the Disease Activity Score (DAS-28-CRP) from baseline to the completion of an up-to 8-week treatment period.
Within-arm change of serum Interferon gamma (IFN-gamma) concentration.
Within-arm change of serum Interleukin-1 beta (IL-1beta) concentration.
Within-arm change of serum Interleukin-6 (IL-6) concentration.
Within-arm change of serum Interleukin-6 (IL-8) concentration.
Within-arm change of serum Tumor Necrosis Factor (TNFa) concentration.
Within-arm change of serum c-reactive protein (CRP) concentration.
Within-arm change of serum cortisol levels.
Within-arm change of serum erythrocyte sedimentation rate (ESR).
Within-arm change on the EQ-5D health questionnaire.
Within-arm change on the Multidimensional Health Assessment Questionnaire (HAQ).
End of study participation
Exit interview questions.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Ultrasound Group
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Splenic Ultrasound · No Placebo Group · N/A

Ultrasound Group
Device
Experimental Group · 1 Intervention: Splenic Ultrasound · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Splenic Ultrasound
2021
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of study participation
Closest Location: University of Minnesota Health Clinics and Surgery Center · Minneapolis, MN
Photo of Minneapolis 1Photo of Minneapolis 2Photo of Minneapolis 3
2019First Recorded Clinical Trial
1 TrialsResearching Rheumatoid Arthritis
3 CompletedClinical Trials

Who is running the clinical trial?

SecondWave Systems Inc.Lead Sponsor
2 Previous Clinical Trials
98 Total Patients Enrolled
DARPA (United States Department of Defense)UNKNOWN
1 Previous Clinical Trials
58 Total Patients Enrolled
University of MinnesotaOTHER
1,227 Previous Clinical Trials
1,454,388 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
1,767 Patients Enrolled for Rheumatoid Arthritis
Erik Peterson, M.D.Principal InvestigatorUniversity of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
1 Previous Clinical Trials
58 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have synovitis in at least 1 joint, you have no alternative diagnosis that better explains the synovitis, and you have a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.