Trials / Completed

CompletedNCT03176927

Biomagnetic Characterization of Gastric Dysrhythmias III

Status: Completed
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 22 (actual)

Sponsor: Vanderbilt University Medical Center · Academic / Other
Sex: All
Age: 12 Years – 80 Years
Healthy volunteers: Accepted

Summary

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

5/23/25. Study record updated to reflect Early Phase 1/Phase 0 trial. The main aim of the study was to evaluate MGG as a device for classification of functional gastric disorders. 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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	magnetogastrogram

Timeline

Start date: 2012-12-01
Primary completion: 2025-05-12
Completion: 2025-05-12
First posted: 2017-06-06
Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03176927. Inclusion in this directory is not an endorsement.