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Behavioural Intervention

Ultrasound Stimulation for Inflammation and Healthy Subjects

N/A
Recruiting
Led By Mark D. Okusa, MD, FASN
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome will be assessed immediately after, within 24 to 48 hours, and 2 weeks after receiving ultrasound stimulation
Awards & highlights

Study Summary

This trial tests if sound waves can reduce inflammation in healthy people.

Eligible Conditions
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome will be assessed immediately after, within 24 to 48 hours, and 2 weeks after receiving ultrasound stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome will be assessed immediately after, within 24 to 48 hours, and 2 weeks after receiving ultrasound stimulation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in concentrations of immune cells and cytokines depending on ultrasound stimulation intensity
Change in concentrations of immune cells and cytokines depending on ultrasound stimulation site
Secondary outcome measures
Distribution of immune cells
Other outcome measures
Participant comfort, experience, and new-onset sensations by questionnaire

Trial Design

2Treatment groups
Active Control
Group I: Group 2Active Control1 Intervention
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.
Group II: Group 1Active Control1 Intervention
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. The two doses will be administered in separate visits with min. 14 days between each stimulation. In both Subgroups, the two doses will be administered in separate visits with min. 14 days between each stimulation.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
759 Previous Clinical Trials
1,245,556 Total Patients Enrolled
Mark D. Okusa, MD, FASNPrincipal InvestigatorUniversity of Virginia

Media Library

Ultrasound-induced Anti-inflammation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05685108 — N/A
Healthy Subjects Research Study Groups: Group 2, Group 1
Healthy Subjects Clinical Trial 2023: Ultrasound-induced Anti-inflammation Highlights & Side Effects. Trial Name: NCT05685108 — N/A
Ultrasound-induced Anti-inflammation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685108 — N/A
~12 spots leftby Jun 2025
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