Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 22, 2020

Keywords

ClinConnect Summary

The purpose of this study is to establish the esophageal pathology findings as imaged with tethered capsule microscopy in subjects with Parkinson Disease. Images from patients with Parkinson disease will be compared to our previously obtained images in healthy subjects to establish the spectrum of esophageal pathologies occurring in patients with Parkinson disease by OCT imaging.

In the case of imaging internal luminal organs, like the esophagus, OCT light is delivered via a long catheter. We have developed a new technique termed Tethered Capsule Endomicroscopy (TCE). TCE involves swallowi...

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Eligibility criteria

• Inclusion Criteria:
• • Idiopathic Parkinson's disease as defined by the United Kingdom PD Society Brain Bank Criteria
• • Parkinson Disease Hoehn and Yahr stage 2-4
• • Subjects on stable dose of Parkinson Disease medications for at least 4 weeks prior to the study screening
• • Subjects between 40 and 85 years old
• • Subjects who are capable of giving informed consent
• • Subjects who had no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure
• Exclusion Criteria:
• • Atypical or secondary Parkinson Disease
• • Esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
• • Recent intestinal resection (within the last six months)
• • Prior gastric, esophageal or oropharyngeal surgery
• • Inability to swallow capsules
• • Pregnancy, according to patient information