Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
90 participants
INTERVENTIONAL
2019-09-04
2026-09-30
Brief Summary
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Detailed Description
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In the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. Recent modifications of the standard electrogastrogram (EGG) that have increased the number of leads to 25 (termed high-resolution EGG) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. Additionally, the magnetogastrogram (MGG) overcomes many of the inherent limitations of the standard EGG. The goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (EESG) and magnetoesophagogram (MESG) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients.
The main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using EESG/MESG in healthy controls and esophageal dysmotility patients and determine how EESG/MESG rhythm and pattern abnormalities relate to physiologic function.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Controls
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
Achalasia subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
High resolution manometry (HRM)
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
Hypercontractile/spastic disorder subjects
Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
High resolution manometry (HRM)
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
Interventions
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Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
High resolution manometry (HRM)
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.
Exclusion Criteria
* Due to interference with signal acquisition, subjects with contraindication to undergoing an MRI scan as noted in the MRI Safety checklist by Vanderbilt University Medical Center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo SQUID, but can still be eligible to do cutaneous EESG.
* Morbid obesity (these patients are potentially unable to lie under the current generation of SQUID devices)
* Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded
18 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Dhyanesh Patel
Principal Investigator
Principal Investigators
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Dhyanesh Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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191280
Identifier Type: -
Identifier Source: org_study_id
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