Biomagnetic Characterization of Gastric Dysrhythmias III

NCT03176927 | Completed Early Phase 1 DMC

• 2 other identifiers: IRB# 121501R01DK058697
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

magnetogastrogram; gastroparesis; electrogastrogram; gastric slow wave

Outcome Measures

Primary Outcomes (1)

• Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach

  1 day

Secondary Outcomes (4)

• 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

Study Arms (5)

Gastroparesis

EXPERIMENTAL

magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis

Diagnostic Test: magnetogastrogram

Gastrectomy

EXPERIMENTAL

magnetogastrogram Total or partial gastrectomy group

Diagnostic Test: magnetogastrogram

Functional dyspepsia

EXPERIMENTAL

magnetogastrogram Children with functional dyspepsia

Diagnostic Test: magnetogastrogram

Chronic nausea

EXPERIMENTAL

magnetogastrogram Children with chronic nausea

Diagnostic Test: magnetogastrogram

Control participants

EXPERIMENTAL

magnetogastrogram Group without any gastrointestinal diseases.

Diagnostic Test: magnetogastrogram

Interventions

magnetogastrogram DIAGNOSTIC_TEST

Chronic nausea; Control participants; Functional dyspepsia; Gastrectomy; Gastroparesis

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• Bradshaw LA, Cheng LK, Chung E, Obioha CB, Erickson JC, Gorman BL, Somarajan S, Richards WO. Diabetic gastroparesis alters the biomagnetic signature of the gastric slow wave. Neurogastroenterol Motil. 2016 Jun;28(6):837-48. doi: 10.1111/nmo.12780. Epub 2016 Feb 3.

  PMID: 26839980 RESULT

• Bradshaw LA, Kim JH, Somarajan S, Richards WO, Cheng LK. Characterization of Electrophysiological Propagation by Multichannel Sensors. IEEE Trans Biomed Eng. 2016 Aug;63(8):1751-9. doi: 10.1109/TBME.2015.2502065. Epub 2015 Nov 19.

  PMID: 26595907 RESULT

• Kim JH, Pullan AJ, Bradshaw LA, Cheng LK. Influence of body parameters on gastric bioelectric and biomagnetic fields in a realistic volume conductor. Physiol Meas. 2012 Apr;33(4):545-56. doi: 10.1088/0967-3334/33/4/545. Epub 2012 Mar 14.

  PMID: 22415019 RESULT

• Somarajan S, Cassilly S, Obioha C, Richards WO, Bradshaw LA. Effects of body mass index on gastric slow wave: a magnetogastrographic study. Physiol Meas. 2014 Feb;35(2):205-15. doi: 10.1088/0967-3334/35/2/205. Epub 2014 Jan 7.

  PMID: 24398454 RESULT

• Somarajan S, Muszynski ND, Obioha C, Richards WO, Bradshaw LA. Biomagnetic and bioelectric detection of gastric slow wave activity in normal human subjects--a correlation study. Physiol Meas. 2012 Jul;33(7):1171-9. doi: 10.1088/0967-3334/33/7/1171. Epub 2012 Jun 27.

  PMID: 22735166 RESULT

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonard A Bradshaw, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Surgery

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: June 6, 2017
• Study Start: December 28, 2012
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)