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

Primary Purpose

Arterial Stiffness, Magnetic Field Exposure, Peripheral Arterial Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

magnet and sham

About this trial

This is an interventional basic science trial for Arterial Stiffness

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age between 18-35 years
No known neurological deficit
No known cardiovascular condition

Exclusion Criteria:

Unable or unwilling to lie reasonably still for about 55 minutes
Known to have diabetes of any type
Having any metallic or wire implant

Sites / Locations

Nova Southeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Healthy Adults-magnet

Healthy Adults-sham

Arm Description

Healthy adults with magnet and/or sham

Outcomes

Primary Outcome Measures

Effect of magnet on skin blood flow

skin blood flow

Effect of magnet on arterial pulses

Pulse values and paterns

Characterization of temporal pattern of pulse changes and their amelioration

variability with and without normalization

Secondary Outcome Measures

Full Information

NCT ID

NCT04539704

First Posted

August 31, 2020

Last Updated

April 19, 2023

Sponsor

Nova Southeastern University

1. Study Identification

Unique Protocol Identification Number

NCT04539704

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Stiffness, Magnetic Field Exposure, Peripheral Arterial Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Masking Description

Subjects and coinvestigators making measurements are blinded to which devices are the active magnets and which are the sham magnets. Only the PI will have that information.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Adults-magnet

Arm Type

Experimental

Arm Description

Healthy adults with magnet and/or sham

Arm Title

Healthy Adults-sham

Arm Type

Sham Comparator

Arm Description

Healthy adults with magnet and/or sham

Intervention Type

Device

Intervention Name(s)

magnet and sham

Intervention Description

In same subject some areas will have magnet and others will have sham

Primary Outcome Measure Information:

Title

Effect of magnet on skin blood flow

Description

skin blood flow

Time Frame

one hour

Title

Effect of magnet on arterial pulses

Description

Pulse values and paterns

Time Frame

one hour

Title

Characterization of temporal pattern of pulse changes and their amelioration

Description

variability with and without normalization

Time Frame

one hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18-35 years No known neurological deficit No known cardiovascular condition Exclusion Criteria: Unable or unwilling to lie reasonably still for about 55 minutes Known to have diabetes of any type Having any metallic or wire implant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harvey Mayrovitz

Phone

9547429921

mayrovit@nova.edu

Facility Information:

Facility Name

Nova Southeastern University

City

Davie

State/Province

Florida

ZIP/Postal Code

33328

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harvey Mayrovitz

Phone

954-205-7199

mayrovit@nova.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33283550

Citation

Mayrovitz HN, Astudillo A, Shams E. Finger skin blood perfusion during exposure of ulnar and median nerves to the static magnetic field of a rare-earth magnet: A randomized pilot study. Electromagn Biol Med. 2021 Jan 2;40(1):1-10. doi: 10.1080/15368378.2020.1856682. Epub 2020 Dec 5.

Results Reference

derived

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

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