Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
- Conditions
- Parkinson DiseaseParkinson
- Interventions
- Device: OCT - TCE
- Registration Number
- NCT04566341
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Feasibility of OCT TCE in identifying signs of PD OCT - TCE Participants that fulfill our Inclusion/Exclusion criteria will be asked to swallow our Capsule Imaging device.
- Primary Outcome Measures
Name Time Method Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls Imaging data is collected during the procedure and analyzed within 1 year of collection. 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.
Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy Imaging data is collected during the procedure and analyzed within 1 year of collection. The image adequacy will be assessed qualitatively (resolution, contrast, etc).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States