Sensory Effects of Rapidly-Changing Magnetic Fields

This study is being conducted to improve magnetic resonance imaging (MRI) scans by reducing the time required for imaging. Experience has shown that unpleasant side-effects from magnetic pulses used in MRI (for example, tingling or tapping sensations) can be reduced when the magnetic pulses are shortened. In this study, we will explore whether this effect holds true when very short magnetic pulses are applied.

Study Overview

• Status: Completed
• Conditions: Sensory Disorders
• Intervention / Treatment: Device: High pulsed magnetic fields

Detailed Description

See above

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Freeville, New York, United States, 13068
      • Applied Pulsed Power

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults over 18, capable of informed consent

Exclusion Criteria:

• History of arrhythmia. Has implanted pacemaker or defibrillator, right wrist-to-sternum distance of less than 60 centimeters, visible tattoos of the right hand or wrist, or with any metallic objects that cannot be removed from the right hand or wrist. Irregular or imperceptible pulse. Heart rate less than 50 beats per minute or more than 100 per minute, resting respiratory rate greater than 25 per minute, diastolic blood pressure less than 50. Solid meal ingested within 2 hours prior to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm study; Each subjects will undergo escalating exposure to magnetic field	Device: High pulsed magnetic fields; Magnetic fields will escalate in strength; Other Names: Pulser is custom built by Applied Pulsed Power, Ithaca NY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Discomfort Under Applied Pulsed Magnetic Fields	Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.	Bioeffects will be assessed within the five-minute application of each pulse sequence

Collaborators and Investigators

• Sponsor: Weinberg Medical Physics LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Stanley Fricke, PhD, Children's National Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): July 3, 2012

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Magnetic fields discomfort
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders
• Other Study ID Numbers: WMP 5.0; R42HL086294-04 (U.S. NIH Grant/Contract); 9R42NS073289-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO