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

NCT ID: NCT04566341

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-04
• Study Completion Date: 2029-12-31

Brief 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.

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.

Conditions

Parkinson Disease; Parkinson

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

OCT - TCE

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, M.D, PhD.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P001226

Identifier Type: -

Identifier Source: org_study_id