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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566341
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, 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.

Condition or disease Intervention/treatment
Parkinson Disease Parkinson Device: OCT - TCE

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.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org
Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anita Chung, RN    617-724-4515    Tearneylabtrials@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Guillermo Tearney, M.D, PhD. Massachusetts General Hospital
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Responsible Party: Guillermo Tearney, Guillermo J. Tearney, MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04566341    
Other Study ID Numbers: 2018P001226
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
OCT
Optical Coherence Tomography
TCE
Tethered Capsule Endomicroscopy
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases