Biomagnetic Characterization of Gastric Dysrhythmias III



Status:Enrolling by invitation
Conditions:Gastroesophageal Reflux Disease , Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:12 - 80
Updated:9/27/2018
Start Date:December 2012
End Date:August 2020

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There is a tremendous clinical need for a noninvasive technique that can assess gastric
electrical activity and would be repeatable without any exposure to radiation. Investigators
developed a new technique allowing to use noninvasive methods to assess bioelectrical
activity in the gastrointestinal system. This has enabled to characterize the normal and
pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG)
records. Primary hypothesis for this proposal is that analysis of gastric slow wave
uncoupling and propagation in multichannel MGG discriminates between normal and pathological
gastric electrical activity. Eventually, investigators envision this research leading to new
insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and
chronic idiopathic nausea that would inform clinical management of these debilitating
diseases.

Studies have demonstrated that the magnetogastrogram (MGG) records the same gastric slow wave
activity that detect with serosal and mucosal electrodes. The upgraded magnetometer will
improve the spatial resolution resulting in increased sensitivity for detecting and
characterizing both abnormal frequency dynamics and abnormal spatiotemporal patterns. The
spatiotemporal data collected with multichannel Superconducting QUantum Interference Device
(SQUID) biomagnetometer has allowed , for the first time, to characterize propagation of the
gastric slow wave noninvasively. In addition to frequency dynamic changes, which are the only
reliable parameters from cutaneous electrogastrogram (EGG), and which still do not
necessarily correlate well with disease, the MGG reflects normal and abnormal gastric slow
wave activity. Furthermore, for the first time, investigators have demonstrated that
propagation characteristics determined magnetically distinguish normal subjects from patients
with gastroparesis. Also for the first time, investigators have been able to detect the
gradient in gastric propagation velocity noninvasively in animal subjects. However,
investigators still have unresolved questions about how MGG propagation rhythm and pattern
disturbances may specify functional disorders.

Inclusion Criteria:

- Participants between ages 12-80

- Diabetic patients with gastroparesis, diabetic patients without gastroparesis and who
are willing to have a gastric emptying test if they have not had one in the last 6
months and an IV inserted.

- Patients with idiopathic gastroparesis

- Total or partial gastrectomy patients

- Children (ages 12-17) with functional dyspepsia

- Children (ages 12-17) with chronic nausea

Exclusion Criteria:

- Those with claustrophobia who cannot lie still under the SQUID for the length of time
required.

- Normal participants with known intestinal complications

- Pregnant females (females who are able to have children will be given a pregnancy
test).

- Morbid obesity (these patients are presumably unable to lie under the current
generation of SQUID devices).

- Patients with a history of cardiac arrhythmias, taking anticoagulants, or greater than
80 years of age will be excluded.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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