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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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