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Trial Outcomes & Findings for Sensory Effects of Rapidly-Changing Magnetic Fields (NCT NCT01632800)

NCT ID: NCT01632800

Last Updated: 2019-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Bioeffects will be assessed within the five-minute application of each pulse sequence

Results posted on

2019-10-08

Participant Flow

Participant milestones

Participant milestones
Measure
Single Arm Study
Each subjects will undergo escalating exposure to magnetic field High pulsed magnetic fields: Magnetic fields will escalate in strength
Overall Study
STARTED
26
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Single Arm Study
Each subjects will undergo escalating exposure to magnetic field High pulsed magnetic fields: Magnetic fields will escalate in strength
Overall Study
Subject did not fit in apparatus
1

Baseline Characteristics

Sensory Effects of Rapidly-Changing Magnetic Fields

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Arm Study
n=25 Participants
Each subjects will undergo escalating exposure to magnetic field High pulsed magnetic fields: Magnetic fields will escalate in strength
Age, Continuous
40.4 years
STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
24 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
25 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Single Arm Study
n=25 Participants
Each subjects will undergo escalating exposure to magnetic field High pulsed magnetic fields: Magnetic fields will escalate in strength
Degree of Discomfort Under Applied Pulsed Magnetic Fields
0 percentage of subjects with discomfort

Adverse Events

Single Arm Study

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irving Weinberg MD PhD

Weinberg Medical Physics LLC

Phone: 3013467944

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place