NCT04566341

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-04
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2020-09-28
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study