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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство OCT - TCE
  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.

Первичные конечные точки

• Feasibility of OCT TCE to identify Parkinson's Disease based on image adequacy [Срок оценки: 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 [Срок оценки: Imaging data is collected during the procedure and analyzed within 1 year of collection.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT04566341 · 2018P001226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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