Biomagnetic Characterization of Gastric Dysrhythmias III

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Biomagnetic Characterization of Gastric Dysrhythmias III

Conditions
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Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis, Total or Partial Gastrectomy, Chronic Nausea, Functional Dyspepsia

Intervention / Treatment
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* Diagnostic Test: magnetogastrogram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastroparesis<br>magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis | Diagnostic Test: magnetogastrogram<br> <br> |
| Experimental: Gastrectomy<br>magnetogastrogram Total or partial gastrectomy group | Diagnostic Test: magnetogastrogram<br> <br> |
| Experimental: Functional dyspepsia<br>magnetogastrogram Children with functional dyspepsia | Diagnostic Test: magnetogastrogram<br> <br> |
| Experimental: Chronic nausea<br>magnetogastrogram Children with chronic nausea | Diagnostic Test: magnetogastrogram<br> <br> |
| Experimental: Control participants<br>magnetogastrogram Group without any gastrointestinal diseases. | Diagnostic Test: magnetogastrogram<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of gastric slow wave propagation velocity in gastroparesis patients |  | 1 day | 
| Measurement of invasive serosal electromyogram before and after partial/total gastrectomy. |  | day 1 and day 30 | 
| Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy. |  | day 1 and day 30 | 
| Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetogastrogram, gastroparesis, electrogastrogram, gastric slow wave