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

Sponsor
Nova Southeastern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04539704
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: magnet and sham
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
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.
Primary Purpose:
Basic Science
Official Title:
Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy Adults-magnet

Healthy adults with magnet and/or sham

Device: magnet and sham
In same subject some areas will have magnet and others will have sham
Sham Comparator: Healthy Adults-sham

Healthy adults with magnet and/or sham

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

Outcome Measures

Primary Outcome Measures

  1. Effect of magnet on skin blood flow [one hour]

    skin blood flow

  2. Effect of magnet on arterial pulses [one hour]

    Pulse values and paterns

  3. Characterization of temporal pattern of pulse changes and their amelioration [one hour]

    variability with and without normalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nova Southeastern University Davie Florida United States 33328

Sponsors and Collaborators

  • Nova Southeastern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harvey Mayrovitz, Professor, Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT04539704
Other Study ID Numbers:
  • 2019-598-NSU
First Posted:
Sep 7, 2020
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases

Study Results

No Results Posted as of Apr 18, 2022