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Clinical Trials/NCT04539704
NCT04539704CompletedNot Applicable

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

Nova Southeastern University1 site in 1 country12 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Characterization of temporal pattern of pulse changes and their amelioration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
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.

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Healthy Adults-magnet

Experimental

Healthy adults with magnet and/or sham

Intervention: magnet and sham (Device)

Healthy Adults-sham

Sham Comparator

Healthy adults with magnet and/or sham

Intervention: magnet and sham (Device)

Outcomes

Primary Outcomes

Characterization of temporal pattern of pulse changes and their amelioration

Time Frame: one hour

variability with and without normalization

Effect of magnet on skin blood flow

Time Frame: one hour

skin blood flow

Effect of magnet on arterial pulses

Time Frame: one hour

Pulse values and paterns

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harvey N. Mayrovitz, PhD

Professor

Nova Southeastern University

Study Sites (1)

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