Biomagnetic Characterization of Gastric Dysrhythmias III

October 12, 2023 updated by: Alan Bradshaw, Vanderbilt University Medical Center
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastroparesis

magnetogastrogram

Diabetes with and without gastroparesis ; Idiopathic gastroparesis
Diagnostic test: magnetogastrogram
Experimental: Gastrectomy

magnetogastrogram

Total or partial gastrectomy group
Diagnostic test: magnetogastrogram
Experimental: Functional dyspepsia

magnetogastrogram

Children with functional dyspepsia
Diagnostic test: magnetogastrogram
Experimental: Chronic nausea

magnetogastrogram

Children with chronic nausea
Diagnostic test: magnetogastrogram
Experimental: Control participants

magnetogastrogram

Group without any gastrointestinal diseases.
Diagnostic test: magnetogastrogram

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Leonard A Bradshaw, PhD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 121501
  • R01DK058697 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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