Biomagnetic Characterization of Gastric Dysrhythmias III

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03176927
Study type	Interventional
Source	Vanderbilt University Medical Center
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	December 2012
Completion date	August 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04464369` - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial	Phase 4
Completed	`NCT01671670` - Acupuncture for Patients With Function Dyspepsia	Phase 2/Phase 3
Completed	`NCT00987805` - Efficacy of Banhasasim-tang on Functional Dyspepsia	Phase 4
Completed	`NCT00693407` - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation	N/A
Completed	`NCT00761358` - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia	Phase 3
Recruiting	`NCT01240096` - Mirtazapine Versus Placebo in Functional Dyspepsia	Phase 4
Recruiting	`NCT04540549` - Effects of Exercise on Functional Dyspepsia Based on Rome IV	N/A
Recruiting	`NCT03652571` - Nortriptyline for the Treatment of Functional Dyspepsia	Phase 3
Recruiting	`NCT06068114` - Gastric Pathophysiology in Diabetes
Recruiting	`NCT03825692` - International Clinical Study of Zhizhu Kuanzhong Capsule	Phase 4
Not yet recruiting	`NCT04548011` - Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia	N/A
Terminated	`NCT02567578` - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia	Phase 2
Completed	`NCT03007433` - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging	N/A
Active, not recruiting	`NCT00990405` - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia	Phase 4
Completed	`NCT00404534` - Helicobacter Eradication Relief of Dyspeptic Symptoms	Phase 3
Completed	`NCT03043625` - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia	N/A
Completed	`NCT03225248` - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia	Phase 3
Recruiting	`NCT05587127` - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia	N/A
Recruiting	`NCT01021475` - Does Visceral Manipulation Works in Treating Functional Dyspepsia?	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.