Sensory Effects of Rapidly-Changing Magnetic Fields

Sensory Disorders Clinical Trial

Official title:

Sensory Effects of Rapidly-Changing Magnetic Fields

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632800
• Other study ID #: WMP 5.0
• Secondary ID: R42HL086294-049R
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2019
• Source: Weinberg Medical Physics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sensation Disorders
• Sensory Disorders

Intervention

Device:
• High pulsed magnetic fields
Magnetic fields will escalate in strength

Locations

Country	Name	City	State
United States	Applied Pulsed Power	Freeville	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weinberg Medical Physics LLC	National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Bioeffects will be assessed within the five-minute application of each pulse sequence