Parkinson Disease Clinical Trial
Official title:
Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
Verified date | May 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy | The image adequacy will be assessed qualitatively (resolution, contrast, etc). | Imaging data is collected during the procedure and analyzed within 1 year of collection. | |
Primary | Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls | 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. | Imaging data is collected during the procedure and analyzed within 1 year of collection. |
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