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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04566341
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 4, 2019
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Massachusetts General Hospital· Boston, MA

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