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Sensory Effects of Rapidly-Changing Magnetic Fields

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632800
First Posted: July 3, 2012
Last Update Posted: June 15, 2016
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Weinberg Medical Physics LLC
  Purpose
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 Intervention
Sensory Disorders Device: High pulsed magnetic fields

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Sensory Effects of Rapidly-Changing Magnetic Fields

Further study details as provided by Weinberg Medical Physics LLC:

Primary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
See above
  Eligibility

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.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01632800


Locations
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)
Investigators
Principal Investigator: Stanley Fricke, PhD Children's Research Institute
  More Information

Responsible Party: Weinberg Medical Physics LLC
ClinicalTrials.gov Identifier: NCT01632800     History of Changes
Other Study ID Numbers: WMP 5.0
R42HL086294-04 ( U.S. NIH Grant/Contract )
9R42NS073289-06 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2010
First Posted: July 3, 2012
Results First Submitted: May 7, 2016
Results First Posted: June 15, 2016
Last Update Posted: June 15, 2016
Last Verified: May 2016
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:
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms