Back to resultsSensory Effects of Rapidly-Changing Magnetic Fields
Primary Purpose
Sensory Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High pulsed magnetic fields
Sponsored by
About this trial
This is an interventional basic science trial for Sensory Disorders focused on measuring Magnetic fields discomfort
Eligibility 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.
Sites / Locations
- Applied Pulsed Power
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm study
Arm Description
Each subjects will undergo escalating exposure to magnetic field
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01632800
First Posted
March 17, 2010
Last Updated
October 1, 2019
Sponsor
Weinberg Medical Physics LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT01632800
Brief Title
Sensory Effects of Rapidly-Changing Magnetic Fields
Official Title
Sensory Effects of Rapidly-Changing Magnetic Fields
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weinberg Medical Physics LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
See above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensory Disorders
Keywords
Magnetic fields discomfort
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Each subjects will undergo escalating exposure to magnetic field
Intervention Type
Device
Intervention Name(s)
High pulsed magnetic fields
Other Intervention Name(s)
Pulser is custom built by Applied Pulsed Power, Ithaca NY
Intervention Description
Magnetic fields will escalate in strength
Primary Outcome Measure Information:
Title
Degree of Discomfort Under Applied Pulsed Magnetic Fields
Description
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.
Time Frame
Bioeffects will be assessed within the five-minute application of each pulse sequence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Fricke, PhD
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Pulsed Power
City
Freeville
State/Province
New York
ZIP/Postal Code
13068
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sensory Effects of Rapidly-Changing Magnetic Fields
We'll reach out to this number within 24 hrs