Healthy VolunteerNCT03548116
Biological Effects of Ultrasound Insonification of the Spleen
A study testing Ultrasound in people with Healthy Volunteer, run by John Pellerito at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 46Show fewer
- 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
- history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
- previous episodes of pancreatitis
- spinal disorders
- chronic pain syndromes
- history of thrombosis or bleeding disorders
- stage III-IV pressure ulcers
- sickle cell anemia or other anemia syndromes
- monocytosis
- thrombocytopenia
- diagnosed with fever of unknown origin (FUO)
- previously or currently implanted vagus nerve stimulator
- previously or currently implanted spinal cord stimulator
- other chronically-implanted electronic medical device
- history of seizures
- history of cancer
- Individuals who have taken any of the following medications within one week of receiving ultrasound delivery:
- anti-coagulant (Coumadin, Xarelto)
- anti-platelet (aspirin, Plavix)
- anti-inflammatory (aspirin, NSAIDs)
- anti-hypertensive (α-methyldopa)
- epinephrine-related drugs, norepinephrine-related drugs, and drugs that stimulate release of epinephrine and/or norepinephrine (Micronefrin, Asthmanefrin)
- immunosuppressive agents (steroids, newer immunomodulatory drugs)
- alpha and/or beta adrenoceptor blocking agents
- anti-seizure medications
- other medications, supplements, etc. that may interfere with the ultrasound delivery or study results
- Individuals with a substance abuse (alcoholism or other) problem
- Individuals that consumed alcohol within 4 days of the baseline visit
- Individuals currently using or have used tobacco or nicotine products within the past 1 month
- Individuals currently using or have used recreational drugs within the past 1 month
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
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.
Read the detailed 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.
- Conditions
- Healthy Volunteer
- Being tested
- Ultrasound, Sham Ultrasound
- Keywords
- Healthy Volunteer, Ultrasound, Insonification, Spleen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
A specially designed ultrasound will be placed against the abdomen of an individual in order to administer low levels of insonification to the spleen.
Sham UltrasoundDevice
A specially designed ultrasound will be placed against the abdomen of an individual in order to administer sham insonification to the spleen.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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. Receives: 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. Receives: 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. Receives: 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). Receives: Device: Sham Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 to determine whether ultrasound delivery to the spleen leads to transient tissue displacement that is correlated to organ-specific biological effects is measured as a statistically significant correlation between the magnitude of transient displacement and the biological effects.
Measured: The secondary outcome will be assessed approximately every 15 seconds during the approximately 10-minute ultrasound.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start23 Apr 2018
- Primary completion13 Mar 2020
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Pellerito
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor-investigator, John Pellerito, Northwell Health
- Investigators
- John Pellerito, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548116
- Sponsor's protocol ID
- 17-0859
- Status last verified
- Dec 2021
- First submitted
- 11 May 2018
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently, there are no plans to make individual participant data available.
Publications
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.
PubMed 27382171Zeng 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.
PubMed 26406372Parker JL, Cameron T. Technology for Peripheral Nerve Stimulation. Prog Neurol Surg. 2015;29:1-19. doi: 10.1159/000434651. Epub 2015 Sep 4.
PubMed 26394391Birk 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.
PubMed 26394389Tracey KJ. Physiology and immunology of the cholinergic antiinflammatory pathway. J Clin Invest. 2007 Feb;117(2):289-96. doi: 10.1172/JCI30555.
PubMed 17273548Martelli 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.
PubMed 24411268Juan 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.
PubMed 25165410Goggins 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.
PubMed 40622772
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Effects of Ultrasound Insonification of the Spleen
- ClinicalTrials.gov ID
- NCT03548116
- Acronym / sponsor ID
- 17-0859
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, Ultrasound, Insonification, Spleen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (actual)
- Lead sponsor
- John PelleritoUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Sham comparator | Device: Sham UltrasoundIndividuals 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). |
| Group 2 | Experimental | Device: UltrasoundIndividuals 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). |
| Group 3 | Experimental | Device: UltrasoundIndividuals 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). |
| Group 4 | Sham comparator | Device: Sham UltrasoundIndividuals will receive sham non-imaging mode ultrasound (control group) delivered to the lower, middle, and upper spleen based on the spleen's size. |
| Group 5 | Experimental | Device: UltrasoundIndividuals will receive half-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size. |
| Group 6 | Experimental | Device: UltrasoundIndividuals will receive full-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size. |
| Group 7 | Sham comparator | Device: Sham UltrasoundIndividuals 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (46 listed)
- 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:
- Individuals who have taken any of the following medications within one week of receiving ultrasound delivery:
- Individuals with a substance abuse (alcoholism or other) problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundA specially designed ultrasound will be placed against the abdomen of an individual in order to administer low levels of insonification to the spleen. | Device | Group 2, Group 3, Group 5, Group 6 |
| Sham UltrasoundA specially designed ultrasound will be placed against the abdomen of an individual in order to administer sham insonification to the spleen. | Device | Group 1, Group 4, Group 7 |
Primary outcome
Anti-inflammatory Response
Time frame: The primary outcome will be assessed before ultrasound and at 1-hour, 2-hours, and 24-hours after receiving ultrasound.
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.
1 secondary outcome
Transient Tissue Displacement
Time frame: The secondary outcome will be assessed approximately every 15 seconds during the approximately 10-minute ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 27382171Koopman 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.
- Background: PubMed 26406372Zeng 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.
- Background: PubMed 26394391Parker JL, Cameron T. Technology for Peripheral Nerve Stimulation. Prog Neurol Surg. 2015;29:1-19. doi: 10.1159/000434651. Epub 2015 Sep 4.
- Background: PubMed 26394389Birk 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.
- Background: PubMed 17273548Tracey KJ. Physiology and immunology of the cholinergic antiinflammatory pathway. J Clin Invest. 2007 Feb;117(2):289-96. doi: 10.1172/JCI30555.
- Background: PubMed 24411268Martelli 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.
- Background: PubMed 25165410Juan 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.
- Derived from this study: PubMed 40622772Goggins 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.
- Stimulating Peripheral Activity to Relieve Conditions (SPARC)Link provided by the sponsor.
- Electrical PrescriptionsLink provided by the sponsor.
- Ultrasonic Stimulation of Peripheral Nervous TissueLink provided by the sponsor.
- Individual participant dataSharing planned: No. Currently, there are no plans to make individual participant data available.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Pellerito, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Healthy Volunteer, run by John Pellerito at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-inflammatory Response (time frame: The primary outcome will be assessed before ultrasound and at 1-hour, 2-hours, and 24-hours after receiving ultrasound.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548116, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.