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Study of Gastrointestinal Dysfunction in Parkinson's Disease

This study is looking at how Parkinson's disease affects the esophagus, the tube that connects your throat to your stomach. Researchers want to see if a new imaging tool called Tethered Capsule Endomicroscopy (TCE) can safely and effectively take pictures of the esophagus in people with Parkinson's. The TCE is a small capsule you swallow that takes detailed images as it moves through your esophagus. The goal is to identify any changes in the esophagus of people with Parkinson's disease by comparing these images to those from healthy individuals. You might be able to join if you are between 40 and 85 years old, have Parkinson's disease (Hoehn and Yahr stage 2-4), and have been on stable Parkinson's medications for at least four weeks. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an observational study, meaning participants will not receive an experimental treatment. It aims to enroll 20 participants.
What's involved
You will be asked to swallow a TCE capsule. Mild numbing and lubrication spray may be used to help with swallowing. Imaging will be conducted as the TCE moves through your esophagus.
Compensation
Not stated in the trial record.
Follow-up
Imaging data will be analyzed within one year of collection to assess the feasibility and identify morphological changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04566341

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

Enrolling by Invitation
Not specifiedAges 40–85Observational
Massachusetts General Hospital
~20 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:OCT - TCE

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy
Measured over Imaging data is collected during the procedure and analyzed within 1 year of collection.
+1 more outcome measured

Conditions

Parkinson Disease
Parkinson

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Parkinson Disease

NCT04566341

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Guillermo Tearney, M.D, PhD. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacyImaging data is collected during the procedure and analyzed within 1 year of collection.

    The image adequacy will be assessed qualitatively (resolution, contrast, etc).

  • Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controlsImaging data is collected during the procedure and analyzed within 1 year of collection.

    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.