Ultrasound Therapy Effects to Modulate the Inflammatory Reflex

Healthy Clinical Trial

Official title: Ultrasound Therapy Effects to Modulate the Inflammatory Reflex

Status Recruiting

Clinical Trial Summary

This two treatment group study, including sham treatment, attempts to measure how ultrasound frequency, duration, intensity, and duty cycle impact its acute anti-inflammatory effect in healthy volunteers. It also attempts to contribute to the evidence regarding the comfort and safety of using therapeutic ultrasound. This pilot dose-finding study will be the basis for a larger Phase 2 trial in Rheumatoid Arthritis (RA) patients.

Clinical Trial Description

Healthy adults aged 22-65 years old without chronic medical conditions will be candidates for the study (see inclusion and exclusion criteria). Each participant during screening will be counseled on the risks and benefits of participating in the study. As discussed in the compensation section, participants will be offered a monetary award for each study session completed. They will be given an electronic consent form and they will have at least 24 hours to review it and can sign at any point they decide to enroll.

Individuals who are interested in participating will have an initial screening blood draw to assess baseline cytokine levels, blood immunogenicity to Lipopolysaccharide (LPS). First half of the participants i.e. 12 participants will be assigned to the treatment group 1, and each participant in this group will receive 4 interventions over a 4 week period with at least 5 days between interventions, but possibly longer depending on their availability. Second half of the participants will be assigned to the treatment group 2, and each participant in this group will receive 3 interventions over a 3 week period with at least 5 days between interventions, but possibly longer depending on their availability.

Participants in both group will be masked to the interventions they are receive. One of the interventions in group 1 will be a 'sham' condition, while the other three interventions will involve active ultrasound administration. Sham intervention will be administered first, and then the remaining three interventions in group 1 will be randomized. Ultrasound parameters for two of the three interventions in group 2 will be chosen and administered based on most effective parameters from group 1. Interventions in group 2 will not be randomized. The two treatment groups, and the interventions within each group are outlined below. Each experimental intervention was chosen to answer a specific translational question regarding the optimal treatment intensity, duty cycle, frequency, and anatomic location. All of the interventions are below the FDA's safety limit for diagnostic ultrasound.

Blood samples will be taken before each treatment, 2 hours post-treatment and 24 hours post-treatment. The blood samples will be challenged within 1 hour of collection with Lipopolysaccharide (LPS) from E coli to induce ex-vivo inflammation. After processing samples will undergo immunoassay testing to assess cytokine, chemokine, and growth factor levels. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05457907
• Study type: Interventional
• Source: Stanford University
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Completion date: December 2023