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

NCT04566341 | Enrolling By Invitation FDA Device

• 1 other identifier: 2018P001226
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Parkinson

Keywords

OCT; Optical Coherence Tomography; TCE; Tethered Capsule Endomicroscopy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

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.

Feasibility of OCT TCE in identifying signs of PD

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillermo Tearney, M.D, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 28, 2020
• Study Start: May 4, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)