Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03057665 |
| Other study ID # |
H-2008-0099 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2010 |
| Est. completion date |
April 1, 2019 |
Study information
| Verified date |
May 2019 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 .
