Peripheral Blood Flow Responses to Electromagnetic Energy

Exposure to Man-made Visible Light Clinical Trial

Official title:

Peripheral Blood Flow Responses to Electromagnetic Energy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02370199
• Other study ID #: 22652
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Nicole L Lohr, MD, PhD
• Phone: 205-996-3504
• Email: nlohr[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults. All participants will receive red light to their leg. They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.

Description:

670 nm energy in the form of red light dilates isolated blood vessels. This study seeks to measure vessel dilation in human subjects exposed to this energy at different irradiance intensities (25 milliwatts (mW)/cm2 and 75 mW/cm2). The intent of this protocol is to measure blood flow in the gastrocnemius muscle before and after exposure to 670 nm light energy. This protocol will be performed in healthy subjects, who do not meet exclusion criteria. The study consists of one visit. Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream. Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image. After baseline blood flow images are collected, the subject will receive red light energy to the gastrocnemius muscle with concurrent blood flow measurements with contrast ultrasound. The subject will be monitored post procedure and the study will then be completed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Participants will be healthy subjects over the age of 18.

• Men and women will be recruited for participation.

• All ethnicities will be included in this study.

Exclusion Criteria:

Exclusionary criteria include:

• age under 18 years and those over 60 years of age,

• those who are unable to understand the consent process,

• those who cannot read or speak English,

• a history of cancer,

• peripheral artery disease,

• diabetes mellitus,

• active pregnancy,

• hypersensitivity to perflutren contrast agents,

• pulmonary hypertension,

• chronic kidney disease,

• active tobacco or drug use,

• blood pressure over 160/90, BMI>30,

• sickle cell disease, or

• history of intracardiac shunt.

Additional exclusion criteria include:

• a history of coronary artery disease,

• heart failure,

• the presence of an implanted defibrillator or pacemaker,

• a history of heart murmur or rhythm disorder (atrial fibrillation, atrial tachycardia, or ventricular tachycardia),

• neurological diseases such as stroke, and

• any uncontrolled medical conditions.

Related Conditions & MeSH terms

• Exposure to Man-made Visible Light

Intervention

Device:
• 670 nm light
670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2.

Drug:
• octafluropropane
Octofluoropropane will be administered as a continuous infusion prior to the initiation of 670 nm light in order to measure skeletal muscle blood flow.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood flow (using octafluoropropane infusion and ultrasound)	Blood flow changes based on ultrasound imaging	10 minutes