High Resolution Gastric Mapping and Gastroduodenal Manometry

Overview

About this study

The purpose of this study is to use body surface gastric mapping (BSGM) and gastroduodenal manometry (GDM) to (1) identify disturbances and characterize phenotypes in patients with functional dyspepsia, (2) explore correlations between symptoms during the manometry study with those experienced in daily life, and (3) explore the effects of taVNS on gastrointestinal electrical and motor activity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Patients aged 18-80 years with symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months and who have the ability to perform appropriate informed consent will be enrolled.

Exclusion Criteria: 

  • Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (> 460 msec) or bradycardia (< 45 beats/minute)
  • Conditions precluding safe use of taVNS.
  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Use of opioids.
  • Vulnerable study population.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/08/2025. Questions regarding updates should be directed to the study team contact.
 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nicholas Oblizajek, M.D.

Contact us for the latest status

Contact information:

Shelly Ward CCRP

(507) 538-9997

Ward.Shelly1@mayo.edu

More information

Publications

Publications are currently not available