Sensory Effects of Rapidly-Changing Magnetic Fields

NCT01632800 | Completed Results DMC

• 3 other identifiers: WMP 5.0R42HL086294-049R42NS073289-06
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Disorders

Keywords

Magnetic fields discomfort

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm study

EXPERIMENTAL

Each subjects will undergo escalating exposure to magnetic field

Device: High pulsed magnetic fields

Interventions

High pulsed magnetic fields DEVICE

Magnetic fields will escalate in strength

Also known as: Pulser is custom built by Applied Pulsed Power, Ithaca NY

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18, capable of informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weinberg Medical Physics LLC: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Applied Pulsed Power

Freeville, New York, 13068, United States

Location

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Irving Weinberg MD PhD
• Organization: Weinberg Medical Physics LLC

inweinberg@gmail.com

3013467944

Study Officials

• Stanley Fricke, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: July 3, 2012
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 8, 2019
• Results First Posted: June 15, 2016

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)