Optimizing Ultrasound-induced Anti-inflammation in Human Subjects
NCT ID: NCT05685108
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-09-15
2025-10-31
Brief Summary
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Detailed Description
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Recently, the use of pulsed ultrasonic waves to modulate the neuroimmune pathway has gained interest due to its potential in treating inflammatory disorders non-invasively. This study is designed to test the hypothesis that pulsed ultrasound stimulation can be used effectively in human subjects to control pathogenic inflammatory responses. The overall goal of this project is to determine which, if any, ultrasound stimulation protocols are able to restrict the inflammatory response of immune cells collected from healthy subjects post-ultrasound stimulation.
Four different levels of ultrasound intensity ("doses") will be tested in this study to determine the dose(s) capable of producing an anti-inflammatory effect. The doses will be defined in terms of mechanical index and each subject will receive two different doses of ultrasound. In addition, the study will investigate the efficacy of cervical vagus (neck)-targeted ultrasound, given that it may have an effect similar to spleen-targeted ultrasound through upstream vagus nerve modulation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1
In Subgroup 1, individuals will receive pulsed ultrasound with a mechanical index of 0.6 and 1.4 delivered to the splenic hilum.
In Subgroup 2, individuals will receive pulsed ultrasound with a mechanical index of 1.0 and 1.8 delivered to the splenic hilum.
In Subgroup 3, individuals will receive sham treatment and pulsed ultrasound with a mechanical index of 1.4 delivered to the splenic hilum.
In all Subgroups, the two doses will be administered in separate visits with min. 14 days between each stimulation.
Ultrasound stimulation intensity
A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve.
Group 2
Individuals will receive pulsed ultrasound with a mechanical index of 1.4 delivered to the splenic hilum and the cervical vagus nerve. The two doses will be administered in separate visits with min. 14 days between each stimulation.
Ultrasound stimulation site
A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve and the cervical vagus nerve.
Interventions
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Ultrasound stimulation intensity
A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve.
Ultrasound stimulation site
A clinical ultrasound transducer will be placed against the abdomen or neck of an individual in order to administer insonification to the splenic nerve and the cervical vagus nerve.
Eligibility Criteria
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Inclusion Criteria
* Provision of signed and dated informed consent form
* Able to comprehend the study goals and procedures, stated willingness to comply with all study procedures, and availability for the duration of the study
* Considered English proficient so that the subject can follow verbal commands during the ultrasound procedure
* In good general health, as evidenced by medical history
* Laboratory results indicating normal blood count and adequate organ function
* Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion Criteria
* Mean systolic and diastolic blood pressure values during screening of ≥160 and ≥100 mm Hg, respectively, hypertension on non-selective beta-blockers and/or alpha-methyl dopa, or hypertension requiring more than two anti-hypertension medications
* Obesity (body mass index ≥30 kg/m2)
* Use of anti-inflammatory or immunomodulatory medication, such as non- steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or other immunosuppressants, within one week of receiving ultrasound delivery
* Use of anticoagulant drugs (e.g., coumadin, direct oral anticoagulants) or antiplatelet drugs (e.g., aspirin, clopidogrel) within one week of receiving ultrasound delivery
* Pregnancy, breastfeeding, or planning to become pregnant during the study
* Active bacterial or viral infection; febrile illness within 2 weeks of receiving ultrasound delivery
* Known allergic reactions to ultrasound gel
* Treatment with another investigational drug or other intervention within 1 month of receiving ultrasound delivery
* Any vaccination received within 1 month of receiving ultrasound delivery
* Current smoker or nicotine use within 2 weeks of receiving ultrasound delivery
* Use of recreational drugs within 2 weeks of receiving ultrasound delivery
* History of arrythmia (e.g., clinically significant bradycardia, atrial flutter, atrial fibrillation, ventricular arrythmias)
* History of deep vein thrombosis or pulmonary embolism
* History of bleeding disorder
* History of seizure
* History of unilateral or bilateral vagotomy
* Participants with an implantable medical device, such as pacemaker, hearing aid implant, or any implanted electronic device
* Surgery or traumatic injury (e.g., visceral injury, cerebral injury) in the past 3 months
* Prior surgery on thyroid or parathyroid glands, esophagus, stomach, or spleen
* Participant is considered by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluations, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study. outcomes.
25 Years
50 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Mark Okusa, MD
Chief, Division of Nephrology
Principal Investigators
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Mark D. Okusa, MD, FASN
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative Medicine
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Okusa MD, Rosin DL, Tracey KJ. Targeting neural reflex circuits in immunity to treat kidney disease. Nat Rev Nephrol. 2017 Nov;13(11):669-680. doi: 10.1038/nrneph.2017.132. Epub 2017 Oct 3.
Cai J, Nash WT, Okusa MD. Ultrasound for the treatment of acute kidney injury and other inflammatory conditions: a promising path toward noninvasive neuroimmune regulation. Am J Physiol Renal Physiol. 2020 Jul 1;319(1):F125-F138. doi: 10.1152/ajprenal.00145.2020. Epub 2020 Jun 8.
Gigliotti JC, Huang L, Bajwa A, Ye H, Mace EH, Hossack JA, Kalantari K, Inoue T, Rosin DL, Okusa MD. Ultrasound Modulates the Splenic Neuroimmune Axis in Attenuating AKI. J Am Soc Nephrol. 2015 Oct;26(10):2470-81. doi: 10.1681/ASN.2014080769. Epub 2015 Feb 2.
Cotero V, Fan Y, Tsaava T, Kressel AM, Hancu I, Fitzgerald P, Wallace K, Kaanumalle S, Graf J, Rigby W, Kao TJ, Roberts J, Bhushan C, Joel S, Coleman TR, Zanos S, Tracey KJ, Ashe J, Chavan SS, Puleo C. Noninvasive sub-organ ultrasound stimulation for targeted neuromodulation. Nat Commun. 2019 Mar 12;10(1):952. doi: 10.1038/s41467-019-08750-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HSR220029
Identifier Type: -
Identifier Source: org_study_id
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