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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
Participants on stable dose of Parkinson Disease medications for at least 4 weeks prior to the study screening
Participants between 40 and 85 years old
Participants who are capable of giving informed consent

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 participant information

Treatment and study plan

OCT - TCE

Device

Participants will be asked to swallow the TCE. They may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE is past the pharynx. We will advance the TCE until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.

Primary outcomes

Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy

Time frame: Imaging data is collected during the procedure and analyzed within 1 year of collection.

The image adequacy will be assessed qualitatively (resolution, contrast, etc).
Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls

Time frame: Imaging data is collected during the procedure and analyzed within 1 year of collection.

The PI will confirm morphologic changes in the enteric nervous system of the esophagus of Parkinson's Disease subjects compared to matched controls. This is a comparison performed by the PI against historical controls, as this imaging technique is too novel to have standard quality grading.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2029
First posted: Sep 28, 2020
Registry last updated: Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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