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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    Massachusetts General Hospital
Updated on 25 January 2021
Investigator
Anna Gao, RN
Primary Contact
Massachusetts General Hospital (4.5 mi away) Contact

Summary

The goal of this research is to determine (1) the feasibility of tethered capsule OCT esophageal imaging in the Parkinson's Disease population; (2) the morphologic changes in the enteric nervous system of the esophagus in patients with Parkinson's disease.

Description

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 swallowing a tethered capsule that acquires cross-sectional microscopic images of the entire esophagus as it traverses the luminal organ via peristalsis or is pulled up towards the mouth using tether. The catheter is connected to the imaging system, and the side-viewing optical beam rotates either proximally by a motorized rotary joint or distally by a micro-motor, effectuating circular scanning of the lumen wall. Three-dimensional OCT of the entire length of the lumen can be acquired by simultaneous rotation and translation of the focused OCT beam creating a helical pattern.

Details
Condition Parkinson's disease, Parkinson, parkinson's, parkinson disease
Treatment OCT - TCE
Clinical Study IdentifierNCT04566341
SponsorMassachusetts General Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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