Sensory Effects of Rapidly-Changing Magnetic Fields

Not Applicable

Completed

• Conditions: Sensory Disorders
• Interventions: Device: High pulsed magnetic fields

• Registration Number: NCT01632800
• Lead Sponsor: 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.

Detailed Description

See above

Study Timeline

• Study First Submitted: 2010-03-17
• Study Start: 2011-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-03
• Results First Submitted: 2016-05-07
• Results First Submitted QC: 2016-05-07
• Results First Posted: 2016-06-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	High pulsed magnetic fields	Each subjects will undergo escalating exposure to magnetic field

Primary Outcome Measures

Name	Time	Method
Degree of Discomfort Under Applied Pulsed Magnetic Fields	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.

Trial Locations

Locations (1)

Applied Pulsed Power; 🇺🇸 Freeville, New York, United States