Non-invasive Esophageal Testing for Swallowing Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking anticoagulants (blood thinners), you will not be able to participate.

What data supports the effectiveness of the treatment EESG, High resolution manometry (HRM), MESG for swallowing disorders?

The research highlights the importance of using high-resolution manometry (HRM) as a diagnostic tool for esophageal dysphagia, which is a type of swallowing disorder. HRM has been shown to improve the understanding of esophageal structure and function, which can aid in the accurate diagnosis and treatment of swallowing disorders. ^{1 2 3 4 5}

Is non-invasive esophageal testing generally safe for humans?

The research articles provided do not contain specific safety data for non-invasive esophageal testing methods like EESG, HRM, or MESG. ^{6 7 8 9 10}

How is the EESG, MESG treatment different from other treatments for swallowing disorders?

The EESG, MESG treatment is unique because it is a non-invasive method for assessing swallowing disorders, unlike traditional invasive diagnostic tools like endoscopy or manometry. This approach may offer a more comfortable and accessible option for patients. ^{1 4 11 12 13}

Research Team

Dhyanesh Patel, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults over 18 with no gastrointestinal issues, or those getting routine checks for esophageal motility. It's not for people with MRI contraindications like pacemakers, severe obesity, heart rhythm problems, anticoagulant use, or claustrophobia.

Inclusion Criteria

I am 18 or older and getting an HRM test for esophagus issues.

I am over 18 and do not have any known stomach or intestine problems.

Exclusion Criteria

You are extremely overweight and may not fit comfortably under the SQUID device being used in the study.

I do not have a history of heart rhythm problems nor am I on blood thinners.

You are afraid of being in small spaces and cannot stay still during the required test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo EESG and MESG testing to assess esophageal function and motility disorders

3 months

Multiple visits for testing

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• EESG
• High resolution manometry (HRM)
• MESG

Trial Overview The study tests noninvasive methods to record esophageal activity in adults using EESG and MESG alongside High resolution manometry (HRM), which are techniques to measure muscle function and movements of the esophagus.

Participant Groups

Group I: Achalasia subjects Active Control 4 Interventions

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).

Group II: Hypercontractile/spastic disorder subjects Active Control 4 Interventions

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).

Group III: Healthy Controls Active Control 3 Interventions

Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Free from Dysphagia? A Test Battery to Differentiate Between Mild and No Dysphagia. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The GUSS test as a good indicator to evaluate dysphagia in healthy older people: a multicenter reliability and validity study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

White Paper by the European Society for Swallowing Disorders: Screening and Non-instrumental Assessment for Dysphagia in Adults. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Updates on diagnostic modalities for esophageal dysphagia. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Visualizing the Esophagus During Modified Barium Swallow Studies: A Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Age-related impairment of esophagogastric junction relaxation and bolus flow time. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Piecemeal deglutition and dysphagia limit in normal subjects and in patients with swallowing disorders. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

ACG practice guidelines: esophageal reflux testing. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Electrically evoked cerebral potentials during esophageal distension at perception and pain threshold. [2012]

10. China pubmed.ncbi.nlm.nih.gov

[Detection of esophageal intubation-assessment of several methods in clinical anesthesia]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Ten Questions About Barium Esophagography and Dysphagia. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Nursing swallow screens: why is testing water only not enough? [2022]

13. England pubmed.ncbi.nlm.nih.gov

The dysphagia stress test for rapid assessment of swallowing difficulties in esophageal conditions. [2020]