Biological Effects of Ultrasound Insonification of the Spleen

Status Active, not recruiting

Clinical Trial Summary

This is a seven-cohort, double-blinded, randomized, sham-controlled feasibility trial to determine whether organ-specific biological effects are achievable through selective ultrasound of the spleen utilizing low-energy insonification.

Clinical Trial Description

This study will consist of three study visits. At the screening visit, individuals will be asked to undergo a physical and neurological examination, a blood draw of 4 teaspoons, and a urine pregnancy test if of childbearing potential. The participants that clear study screening will be randomized to one of seven groups. The groups consist of: sham insonification at the hilum (connected probe or disconnected probe); half-powered insonification at the hilum; full-powered insonification at the hilum; sham insonification at the lower, middle, and upper spleen; half-powered insonification at the lower, middle, and upper spleen; and full-powered insonification at the lower, middle, and upper spleen. At the baseline visit, individuals will be asked to undergo a physical and neurological examination and a blood draw of 7 teaspoons before receiving ultrasound as per their assigned group. These individuals will then be asked to undergo a blood draw of 5 teaspoons at 1-hour and 2-hours after the ultrasound. Individuals will be asked to return 24 hours later for the follow-up visit, which will include a physical and neurological examination and a blood draw of 9 teaspoons. The blood samples collected before insonification, one hour after insonification, two hours after insonification, and twenty-four hours after insonification will be assessed for changes in biomarkers (substances in the body that indicate the status of a biological process or condition). These biomarkers include cytokines (proteins involved in the immune response), norepinephrine (chemical in the body that transmits signals), glucose (sugar in the blood), and blood cells that are involved in breathing, clotting, and the immune response. The study will be considered complete after completion of enrollment (10 participants in each group, for a study total of 70 participants), completion of study procedures by all participants, and the completion of analysis of identifiable study data. ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteer

Clinical Trial Details

NCT number	NCT03548116
Study type	Interventional
Source	Northwell Health
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 23, 2018
Completion date	November 2022

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