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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04566341
• Other study ID #: 2018P001226
• Status: Enrolling by invitation
• Start date: May 4, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.