By InvitationNot Applicable

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

United States20 participantsStarted 2019-05-04

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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 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 participant information

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy

Timeframe: Imaging data is collected during the procedure and analyzed within 1 year of collection.

Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls

Timeframe: Imaging data is collected during the procedure and analyzed within 1 year of collection.

Trial details

NCT IDNCT04566341

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy

Timeframe: Imaging data is collected during the procedure and analyzed within 1 year of collection.

Feasibility of OCT TCE to identify Parkinson's Disease based on morphological changes compared to matched controls

Timeframe: Imaging data is collected during the procedure and analyzed within 1 year of collection.