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Atomic Magnetometer for Fetal Biomagnetism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057665
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The goal of this study is the evaluation of an atomic magnetometer that is practical for human biomagnetism studies. The investigators have built a device that has the necessary sensitivity, and will be testing it on a small number of adults and approximately 30 healthy pregnant subjects, in preparation for beginning pre-clinical studies of high-risk pregnancies.

Condition or disease Intervention/treatment
Fetal Heart Disorder Device: Atomic Biomagnetometer

Detailed Description:

The goal of this study is evaluation of our atomic magnetometer for adult and fetal MCG studies. The investigators will assess the signal-to-noise and bandwidth performance under human acquisition conditions. They will also gain experience with the practical issues associated with making the measurements on human subjects.

The measurement sessions will take place in the magnetically shielded room in the UW Biomagnetism Laboratory, where similar studies have been made with SQUID detectors for more than 20 years, without incident. The room contains a bed and/or chair on which the subject may comfortably lie or sit.

The subject will remove all metal and magnetic objects (e.g. watches, glasses, jewelry, coins) and change into metal-free clothing. The subject will put on laser eye protection goggles. The subject will lie or sit on the patient bed in the magnetically shielded room with his or her chest (or stomach in the case of a pregnant mother) as close as possible to the magnetometer (typically 1 cm away), and will be monitored closely through a small opening in the shielded room to ensure comfort throughout the study. Positioning of the device with respect to the patient will be done by one of the researchers. In the case of pregnant women, an ultrasound will be taken to ascertain the position of the baby and facilitate initial positioning of the magnetometer. Depending on need for possible further positioning, the researcher may or may not leave the room after device positioning. The subject will be asked to remain still during data acquisition. (Should the subject become uncomfortable or simply need to move around, he or she will have complete freedom to do so and that particular measurement will be terminated.) Visual and audio contact with the subject will be maintained at all times via an open window in the magnetically shielded room. Using the atomic magnetometer, up to five-minute MCG recordings will be made at several locations in order to map the signal. The recordings will be analyzed off-line. An MCG or fMCG may also be recorded with Dr. Wakai's commercial Magnes and Tristan SQUID magnetometers, using similar acquisition parameters and processing procedures as for the AM. The purpose of the SQUID measurement is to compare the attained waveforms. Processing procedures for the SQUID data are identical to the atomic magnetometer data.

A typical recording session will consist of about 10 minutes for magnetometer alignment and optimization, followed by several 5-minute magnetometer acquisition periods separated by rest breaks during which the subject can relax and preliminary data analysis will be conducted by the researchers. The session may be completed by a SQUID measurement, requiring an additional 15 minutes, and by a brief exit interview to see if the subject had any comfort issues that were not identified during the session. The total recording session will take up to 2 hours .

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Atomic Magnetometer for Fetal Biomagnetism
Actual Study Start Date : October 2010
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
Pregnant Women
Measure magnetic field versus time for fetus, using atomic biomagnetometer.
Device: Atomic Biomagnetometer
Measure magnetic field of fetal heartbeat




Primary Outcome Measures :
  1. Assessment of Atomic Magnetometer [ Time Frame: 20-35 week gestation period ]
    Measure single-to-noise for acquisition of fetal magnetocardiograms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 35 normal, nominally healthy adult volunteers (18 years or older) will be studied, including 30 pregnant women. The pregnant women will be healthy women with uncomplicated pregnancies. They will be studied at gestational ages 18-38 weeks, with studies terminating at 38 weeks or before. The non-pregnant adults will be either the PIs or other volunteers who do not have status relationship to the study investigators.
Criteria

Inclusion Criteria:

  • The subjects will be asked if they consider themselves healthy, if they are able to sit or lie still for 5 minute periods during data acquisition, if they have large metal plates, screws, or devices, and if they are pregnant.

Exclusion Criteria:

  • Participants who self-identify as being unhealthy or having complications with their pregnancy. In addition, vulnerable populations such as prisoners, veterans, individuals with impaired decision-making capabilities, and non-English speakers will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057665


Locations
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United States, Wisconsin
Biomagnetism Laboratory
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Thad Walker, PhD Univ. of Wisconsin-Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03057665    
Other Study ID Numbers: H-2008-0099
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases