Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
Parkinson Disease · Parkinson
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 40 years - 85 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 20 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
The purpose of this study is to establish the esophageal pathology findings as imaged with tethered capsule microscopy in participants with Parkinson Disease. Images from participants with Parkinson disease will be compared to our previously obtained images in healthy participants to establish the spectrum of esophageal pathologies occurring in participants 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Study population
Patients of the treating neurologist (a co-investigator) at MGH.
In addition, an online advertisement seeking volunteers will be listed on rally.partners.org
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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
OCT - TCE 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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy
Time frame: Imaging 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 controls
Time frame: Imaging 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Massachusetts General HospitalBoston, Massachusetts, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Massachusetts General Hospital
- Study start
- May 4, 2019 Actual
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Dec 31, 2029 Estimated
- First posted
- Sep 28, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026