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Sensory Effects of Rapidly-Changing Magnetic Fields

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632800
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : June 15, 2016
Last Update Posted : October 8, 2019
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Weinberg Medical Physics LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sensory Disorders Device: High pulsed magnetic fields Not Applicable

Detailed Description:
See above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sensory Effects of Rapidly-Changing Magnetic Fields
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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 Name: Pulser is custom built by Applied Pulsed Power, Ithaca NY

Primary Outcome Measures :
  1. Degree of Discomfort Under Applied Pulsed Magnetic Fields [ Time Frame: Bioeffects will be assessed within the five-minute application of each pulse sequence ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632800

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United States, New York
Applied Pulsed Power
Freeville, New York, United States, 13068
Sponsors and Collaborators
Weinberg Medical Physics LLC
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Stanley Fricke, PhD Children's National Research Institute
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Responsible Party: Weinberg Medical Physics LLC Identifier: NCT01632800    
Other Study ID Numbers: WMP 5.0
R42HL086294-04 ( U.S. NIH Grant/Contract )
9R42NS073289-06 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2012    Key Record Dates
Results First Posted: June 15, 2016
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weinberg Medical Physics LLC:
Magnetic fields discomfort
Additional relevant MeSH terms:
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Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms