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NCT04539704 Clinical Trial

Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow

Peripheral Arterial Disease Clinical Trial

Official title:
Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04539704
Other study ID # 2019-598-NSU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source Nova Southeastern University
Contact Harvey Mayrovitz
Phone 9547429921
Email mayrovit@nova.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to investigate and determine the effects of static magnetic fields produced by a small magnet on peripheral pulses and skin blood flow.

Description:

A specific neodymium magnet and sham device will be placed on certain sites near the ulnar and medial arteries and the effect of such placement on peripheral pulses assessed via PPG on fingers and on skin blood flow via laser Doppler perfusion determined. These assessments will be made while healthy subjects are lying supine on a padded examination table over a time interval of about 45-60 minutes. In addition to the impact that either the magnet or the sham devices have, the pulse and skin blood flow patterns and features will be analyzed from the point of view of sequential variability with and eye toward developing related parameters to potentially improve such variability.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. Age between 18-35 years 2. No known neurological deficit 3. No known cardiovascular condition Exclusion Criteria: 1. Unable or unwilling to lie reasonably still for about 55 minutes 2. Known to have diabetes of any type 3. Having any metallic or wire implant

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• magnet and sham
In same subject some areas will have magnet and others will have sham

Locations
Country Name City State
United States Nova Southeastern University Davie Florida

Sponsors (1)
Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of magnet on skin blood flow skin blood flow one hour
Primary Effect of magnet on arterial pulses Pulse values and paterns one hour
Primary Characterization of temporal pattern of pulse changes and their amelioration variability with and without normalization one hour
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