What this study is
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.
What's being tested
- OCT - TCE
Intervention · DEVICE
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.
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- Parkinson Disease · Parkinson
- Enrolling
- 20 people
- Starts
- 2019-05-04
- Est. completion
- 2029-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Idiopathic Parkinson's disease as defined by the United Kingdom PD Society Brain Bank Criteria
- Parkinson Disease Hoehn and Yahr stage 2-4
- Participants on stable dose of Parkinson Disease medications for at least 4 weeks prior to the study screening
- Participants between 40 and 85 years old
- Participants who are capable of giving informed consent
You can't join if
- 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 participant information
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
Study team
Sponsor
Massachusetts General Hospital
Study ID 2018P001226
Principal investigator
Guillermo Tearney, M.D, PhD.
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.