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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ the outcome will be assessed immediately after, within 24 to 48 hours, and 2 weeks after receiving ultrasound stimulation

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,245,001 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol open to elderly participants aged 85 or higher?

"According to the criteria for this study, any participants must be between 25 and 50 years old."

Answered by AI

What is the aggregate sum of participants engaged in this clinical trial?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is actively recruiting participants and was first posted in December of 2022 with its most recent update being January 6th 2023. The study seeks 30 patients from a single site."

Answered by AI

Are there still opportunities for participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this investigation is currently seeking out participants; it was first posted on December 1st 2022 and has been revised most recently on January 6th 2023. 30 individuals are needed from a single medical centre for the trial to be successful."

Answered by AI

How can I qualify to participate in this trial?

"This research is recruiting 30 adults between the ages of 25 and 50 with no underlying health conditions. In addition to meeting this criteria, potential participants must be able to understand the study's objectives and demonstrate English proficiency during an ultrasound exam; they must also sign a consent form, agree to maintain lifestyle considerations throughout the duration of trial, have normal blood count results, and demonstrate appropriate organ function."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

Mark Okusa, MD 2022. "Optimizing Ultrasound-induced Anti-inflammation in Human Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05685108.