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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04566341
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 43.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Parkinson	Device: OCT - TCE

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Official Title: Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
• Actual Study Start Date: May 4, 2019
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of OCT TCE to identify PD in the Parkinson's Disease Population [Imaging data is collected during the procedure, and analyzed within 1 year of collection.]

   The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirm morphologic changes in the enteric nervous system of the esophagus compared to matched controls. (This is a comparison performed by the PI against historical controls, as this imaging technique is to novel to have standard quality grading.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04566341
• Other Study ID Numbers: 2018P001226
• First Posted: Sep 28, 2020
• Last Update Posted: Sep 28, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Guillermo Tearney, Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital: OCT; Optical Coherence Tomography; TCE; Tethered Capsule Endomicroscopy
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Sep 28, 2020