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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Parkinson
• Intervention / Treatment: Device: OCT - TCE

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of the treating neurologist (a co-investigator) at MGH.

In addition, an online advertisement seeking volunteers will be listed on rally.partners.org

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Feasibility of OCT TCE in identifying signs of PD; Participants that fulfill our Inclusion/Exclusion criteria will be asked to swallow our Capsule Imaging device.	Device: OCT - TCE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy	The image adequacy will be assessed qualitatively (resolution, contrast, etc).	Imaging data is collected during the procedure and analyzed within 1 year of collection.
Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls	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.	Imaging data is collected during the procedure and analyzed within 1 year of collection.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: OCT; Tethered Capsule Endomicroscopy; Optical Coherence Tomography; TCE
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 2018P001226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No