Sensory Effects of Rapidly-Changing Magnetic Fields

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Weinberg Medical Physics LLC
ClinicalTrials.gov Identifier:
NCT01632800
First received: March 17, 2010
Last updated: June 28, 2012
Last verified: June 2012
  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 Phase
Sensory Disorders
Device: High pulsed magnetic fields
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632800

Locations
United States, New York
Applied Pulsed Power
Freeville, New York, United States, 13068
Sponsors and Collaborators
Weinberg Medical Physics LLC
Investigators
Principal Investigator: Stanley Fricke, PhD Children's Research Institute
  More Information

No publications provided

Responsible Party: Weinberg Medical Physics LLC
ClinicalTrials.gov Identifier: NCT01632800     History of Changes
Other Study ID Numbers: WMP 5.0, R42HL086294-04, 9R42NS073289-06
Study First Received: March 17, 2010
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weinberg Medical Physics LLC:
Magnetic fields discomfort

Additional relevant MeSH terms:
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014