Parkinson DiseaseNCT04566341
Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
An observational study of Parkinson Disease and Parkinson, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Parkinson
- What is being tested?
- OCT - TCE
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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 detailed 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.
- Conditions
- Parkinson Disease, Parkinson
- Being tested
- OCT - TCE
- Keywords
- OCT, Optical Coherence Tomography, TCE, Tethered Capsule Endomicroscopy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT - TCEDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OCT - TCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy
The image adequacy will be assessed qualitatively (resolution, contrast, etc).
Measured: 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
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.
Measured: Imaging data is collected during the procedure and analyzed within 1 year of collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start4 May 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, M.D, PhD., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566341
- Sponsor's protocol ID
- 2018P001226
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2020
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04566341
- Acronym / sponsor ID
- 2018P001226
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- OCT, Optical Coherence Tomography, TCE, Tethered Capsule Endomicroscopy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 4 May 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of OCT TCE in identifying signs of PD | – | Device: OCT - TCEParticipants that fulfill our Inclusion/Exclusion criteria will be asked to swallow our Capsule Imaging device. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT - TCEParticipants 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. | Device | Feasibility of OCT TCE in identifying signs of PD |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Tearney, M.D, PhD. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.