Clinical trial NCT04566341: Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
Official title: Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Parkinson Disease
Parkinson
Keywords: OCT
Optical Coherence Tomography
TCE
Tethered Capsule Endomicroscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The treating neurologist (a co-investigator) at MGH will present the study to their patients.

In addition, an online advertisement seeking volunteers will be listed on rally.partners.org

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy
timeFrame: Imaging data is collected during the procedure and analyzed within 1 year of collection.
measure: Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls
timeFrame: Imaging data is collected during the procedure and analyzed within 1 year of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, M.D, PhD.
role: PRINCIPAL_INVESTIGATOR
References: