Biological Effects of Ultrasound Insonification of the Spleen

NCT03548116 | Unknown FDA Device

• 1 other identifier: 17-0859
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Ultrasound; Insonification; Spleen

Outcome Measures

Primary Outcomes (1)

• Anti-inflammatory Response

  The primary outcome to determine whether diagnostic-level ultrasound to the spleen has a biological effect is measured as a statistically significant change in the level of biomarkers associated with the inflammatory response following delivery of ultrasound.

  The primary outcome will be assessed before ultrasound and at 1-hour, 2-hours, and 24-hours after receiving ultrasound.

Secondary Outcomes (1)

• Transient Tissue Displacement

  The secondary outcome will be assessed approximately every 15 seconds during the approximately 10-minute ultrasound.

Study Arms (7)

Group 1

SHAM COMPARATOR

Individuals will receive sham non-imaging mode ultrasound (control group) delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).

Device: Sham Ultrasound

Group 2

EXPERIMENTAL

Individuals will receive half-powered non-imaging mode ultrasound delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).

Device: Ultrasound

Group 3

EXPERIMENTAL

Individuals will receive full-powered non-imaging mode ultrasound delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).

Device: Ultrasound

Group 4

SHAM COMPARATOR

Individuals will receive sham non-imaging mode ultrasound (control group) delivered to the lower, middle, and upper spleen based on the spleen's size.

Device: Sham Ultrasound

Group 5

EXPERIMENTAL

Individuals will receive half-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size.

Device: Ultrasound

Group 6

EXPERIMENTAL

Individuals will receive full-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size.

Device: Ultrasound

Group 7

SHAM COMPARATOR

Individuals will receive sham non-imaging mode ultrasound with a disconnected probe (control group) delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).

Device: Sham Ultrasound

Interventions

Ultrasound DEVICE

A specially designed ultrasound will be placed against the abdomen of an individual in order to administer low levels of insonification to the spleen.

Group 2; Group 3; Group 5; Group 6

Sham Ultrasound DEVICE

A specially designed ultrasound will be placed against the abdomen of an individual in order to administer sham insonification to the spleen.

Group 1; Group 4; Group 7

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals between 18 and 45 years of age
• Individuals without physical disabilities or conditions/diseases that may make them incapable of undergoing the study procedures or otherwise places them at a greater risk of harm
• Individuals without significant past medical or surgical histories that would render them at a greater risk of harm
• Individuals that are considered English Proficient due to the study requirements to follow verbal commands during the ultrasound session
• Individuals that are considered active as assessed by type of activity (i.e., walking, running, etc.) and number of hours a week performing the various activities
• Individuals able to attend all study visits at approximately the same time of day (i.e., 8 - 12 pm)
• Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation

You may not qualify if:

• Individuals participating in another research study that may affect the conduct or results of this study
• Individuals considered substantially overweight or obese via body mass index (≥ 29)
• Individuals having or exhibiting any of the following:
• surgery in the past 90 days
• previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
• recent traumatic injury, including intracerebral hemorrhage and visceral injury
• end stage renal disease and/or uremia
• active malignancy
• previous leukemia and/or lymphoma
• human immunodeficiency virus infection or AIDS
• rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease)
• arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block
• implanted pacemaker or cardioverter/defibrillator (AICD)
• a history of stable or unstable angina, myocardial infarction, angioplasty or coronary arterial by-pass grafting surgery
• history of stroke or TIA

Sponsors & Collaborators

• John Pellerito: lead
• General Electric: collaborator

Study Sites (1)

Northwell Health's The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (8)

• Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. Epub 2016 Jul 5.

  PMID: 27382171 BACKGROUND

• Zeng W, Pirzgalska RM, Pereira MM, Kubasova N, Barateiro A, Seixas E, Lu YH, Kozlova A, Voss H, Martins GG, Friedman JM, Domingos AI. Sympathetic neuro-adipose connections mediate leptin-driven lipolysis. Cell. 2015 Sep 24;163(1):84-94. doi: 10.1016/j.cell.2015.08.055.

  PMID: 26406372 BACKGROUND

• Parker JL, Cameron T. Technology for Peripheral Nerve Stimulation. Prog Neurol Surg. 2015;29:1-19. doi: 10.1159/000434651. Epub 2015 Sep 4.

  PMID: 26394391 BACKGROUND

• Birk DM, Yin D, Slavin KV. Regulation of Peripheral Nerve Stimulation Technology. Prog Neurol Surg. 2015;29:225-37. doi: 10.1159/000434674. Epub 2015 Sep 4.

  PMID: 26394389 BACKGROUND

• Tracey KJ. Physiology and immunology of the cholinergic antiinflammatory pathway. J Clin Invest. 2007 Feb;117(2):289-96. doi: 10.1172/JCI30555.

  PMID: 17273548 BACKGROUND

• Martelli D, McKinley MJ, McAllen RM. The cholinergic anti-inflammatory pathway: a critical review. Auton Neurosci. 2014 May;182:65-9. doi: 10.1016/j.autneu.2013.12.007. Epub 2013 Dec 24.

  PMID: 24411268 BACKGROUND

• Juan EJ, Gonzalez R, Albors G, Ward MP, Irazoqui P. Vagus Nerve Modulation Using Focused Pulsed Ultrasound: Potential Applications and Preliminary Observations in a Rat. Int J Imaging Syst Technol. 2014 Mar 1;24(1):67-71. doi: 10.1002/ima.22080.

  PMID: 25165410 BACKGROUND

• Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Dec 1;36(12):2473-2484. doi: 10.1681/ASN.0000000813. Epub 2025 Jul 7.

  PMID: 40622772 DERIVED

Related Links

• Stimulating Peripheral Activity to Relieve Conditions (SPARC)
• Electrical Prescriptions
• Ultrasonic Stimulation of Peripheral Nervous Tissue

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John Pellerito, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study participants will be blinded to their group assignment for the entire duration of the study. The study investigators will also be blinded to participant assignments on this study, except for the investigators performing the ultrasound procedure, co-investigators randomizing the participants, and co-investigators involved in the study's monitoring.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chairman of Education, Department of Radiology; Director, Peripheral Vascular Laboratory and the Body Imaging Fellowship Program

Model Details: After a screened individual is deemed eligible for continued participation, a study investigator will enter the participant's information into a randomization portal in order to receive the group assignment.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 7, 2018
• Study Start: April 23, 2018
• Primary Completion: March 13, 2020
• Study Completion: November 1, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)