Sensory Effects of Rapidly-Changing Magnetic Fields
This study has been completed.
Sponsor:
Weinberg Medical Physics LLC
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
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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
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 May 21, 2013