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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease, Parkinson

Intervention / Treatment
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* Device: OCT - TCE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feasibility of OCT TCE in identifying signs of PD<br>Participants that fulfill our Inclusion/Exclusion criteria will be asked to swallow our Capsule Imaging device. | Device: OCT - TCE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCE, OCT, Optical Coherence Tomography, Tethered Capsule Endomicroscopy