Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT04566341|
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment|
|Parkinson Disease Parkinson||Device: OCT - TCE|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease|
|Actual Study Start Date :||May 4, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Feasibility of OCT TCE in identifying signs of PD
Participants that fulfill our Inclusion/Exclusion criteria will be asked to swallow our Capsule Imaging device.
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.
- Feasibility of OCT TCE to identify PD in the Parkinson's Disease Population [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirm morphologic changes in the enteric nervous system of the esophagus compared to matched controls. (This is a comparison performed by the PI against historical controls, as this imaging technique is to novel to have standard quality grading.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566341
|Contact: Anita Chung, RN||617-724-4515||Tearneylabtrials@partners.org|
|Contact: Anna Gao, RN||617-643-6092||Tearneylabtrials@partners.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org|
|Principal Investigator:||Guillermo Tearney, M.D, PhD.||Massachusetts General Hospital|