RECRUITING

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

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Conditions

Healthy SubjectsCholinergic anti-inflammatory pathwayVagus nerveCytokinesNeuromodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a feasibility study to determine whether pulsed ultrasound stimulation targeting the splenic nerve or the cervical vagus nerve can elicit an anti-inflammatory immune response in healthy volunteers.

Official Title

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Quick Facts

Study Start:2022-12-01
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05685108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged 25-50 years
  2. * Provision of signed and dated informed consent form
  3. * Able to comprehend the study goals and procedures, stated willingness to comply with all study procedures, and availability for the duration of the study
  4. * Considered English proficient so that the subject can follow verbal commands during the ultrasound procedure
  5. * In good general health, as evidenced by medical history
  6. * Laboratory results indicating normal blood count and adequate organ function
  7. * Agreement to adhere to Lifestyle Considerations throughout study duration.
  1. * Chronic medical conditions, including cancer (in remission or active cancer), cerebrovascular disease, chronic kidney disease, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies), lung disease, liver disease, hypertension, diabetes mellitus type 1 and 2, human immunodeficiency virus infection, primary immunodeficiencies, solid organ or hematopoietic cell transplantation, tuberculosis, and cystic fibrosis, autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease), sickle cell anemia or other anemia syndromes
  2. * 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
  3. * Obesity (body mass index ≥30 kg/m2)
  4. * 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
  5. * Use of anticoagulant drugs (e.g., coumadin, direct oral anticoagulants) or antiplatelet drugs (e.g., aspirin, clopidogrel) within one week of receiving ultrasound delivery
  6. * Pregnancy, breastfeeding, or planning to become pregnant during the study
  7. * Active bacterial or viral infection; febrile illness within 2 weeks of receiving ultrasound delivery
  8. * Known allergic reactions to ultrasound gel
  9. * Treatment with another investigational drug or other intervention within 1 month of receiving ultrasound delivery
  10. * Any vaccination received within 1 month of receiving ultrasound delivery
  11. * Current smoker or nicotine use within 2 weeks of receiving ultrasound delivery
  12. * Use of recreational drugs within 2 weeks of receiving ultrasound delivery
  13. * History of arrythmia (e.g., clinically significant bradycardia, atrial flutter, atrial fibrillation, ventricular arrythmias)
  14. * History of deep vein thrombosis or pulmonary embolism
  15. * History of bleeding disorder
  16. * History of seizure
  17. * History of unilateral or bilateral vagotomy
  18. * Participants with an implantable medical device, such as pacemaker, hearing aid implant, or any implanted electronic device
  19. * Surgery or traumatic injury (e.g., visceral injury, cerebral injury) in the past 3 months
  20. * Prior surgery on thyroid or parathyroid glands, esophagus, stomach, or spleen
  21. * 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.

Contacts and Locations

Study Contact

Mark D. Okusa, MD, FASN
CONTACT
+14349242187
mdo7y@virginia.edu
Igor A. Shumilin, PhD
CONTACT
+14349249691
IAS2N@hscmail.mcc.virginia.edu

Principal Investigator

Mark D. Okusa, MD, FASN
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia, Division of Nephrology; Center for Immunity, Inflammation & Regenerative Medicine
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Mark D. Okusa, MD, FASN, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01
Study Completion Date2023-12

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

  • Cholinergic anti-inflammatory pathway
  • Vagus nerve
  • Cytokines
  • Neuromodulation

Additional Relevant MeSH Terms

  • Healthy Subjects