Parkinson's Disease and Digestive Health
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|ClinicalTrials.gov Identifier: NCT04032262|
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Constipation Gastro-Intestinal Disorder||Diagnostic Test: Gastrointestinal and Parkinson's Disease||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease|
|Actual Study Start Date :||October 4, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Parkinson's Disease Relationship to the GI track
Patients with Parkinson's.
Diagnostic Test: Gastrointestinal and Parkinson's Disease
Subjects with Parkinson's disease will come for visits that will contain questionnaires about their PD, their bowel movements, and do further tests using anal rectal probes to understand further their constipation, and other tests to gather data on their digestion.
- Cortical Evoked Potential (CEP) [ Time Frame: Single Visit, 3 hours ]Bilateral amplitude (microvolts) for ano-rectal CEP responses
- Motor Evoked Potential (MEP) [ Time Frame: Single visit, 2 hours ]Bilateral amplitude (microvolts) for ano-rectal MEP responses
- Gastrointestinal motor function and transit [ Time Frame: 2 visits, 1hour ]The measurements to be obtained are gastric emptying time (GET), small bowel transit time (SBTT), colonic transit time (CTT) and whole gut transit time (WGTT) over a period of 5 days. Tool to be used includes wireless motility capsule and corresponding recorder swallowed on initial visit and returned 5 days later. Specific measurements obtained include time in hours of GET, SBTT, CTT, WGTT. These outcome will only be measured once per subject and not be reassessed.
- Rectal sensorimotor function [ Time Frame: Single visit, 2 hours ]Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
- Anal sensorimotor function [ Time Frame: Single visit, 2 hours ]Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
- Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Single visit, 1 hour ]Used to follow the longitudinal course of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
- Montreal Cognitive Assessment (MoCA) [ Time Frame: Single visit, 1 hour ]Screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A final total score of 26 and above is considered normal.
- Non-motor symptoms questionnaire [ Time Frame: Single visit, 1 hour ]A 30-item screening patient-based questionnaire used to determine the non-motor symptoms experienced by the patient. The points should be totalled to give a score out of 30. A score of under 10 is mild, 10-20 moderate and over 20, severe.
- 36-Item Short Form Survey (SF-36) [ Time Frame: Single visit, 1 hour ]SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
- Stool diary [ Time Frame: 2 visits, 1 hour ]The measurement to be obtained is bowel pattern. Tool to be used include 2-week stool diary. Specific measurements obtained include number of complete spontaneous bowel movements (CSBMs) a week. These outcome will only be measured once per subject and not be reassessed.
- Gastroparesis Cardinal Symptom Index (GCSI) [ Time Frame: Single visit, 1 hour ]The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A six‐point Likert response scale, ranging from 0 (none) to 5 (very severe), with a 2‐week recall period, was used to rate the severity of each symptom. The GCSI total score was constructed as the average of the three symptom sub‐scales. GCSI total scores were in the range 0-5, with higher scores reflecting greater symptom severity.
- Eckdart score (ESS) [ Time Frame: Single visit, 1 hour ]The ESS is a 4 item self‐report scale measuring weight loss in kilograms, chest pain, regurgitation, and dysphagia. Each item is graded on a score of 0 to 3, with a maximum score of 12. Scores greater than or equal to 3 are considered suggestive of active achalasia. The ESS is widely used in both clinical and research settings as a gold standard for measuring achalasia symptom severity.
- Breath testing [ Time Frame: Single visit, 3 hours ]The measurement to be obtained is presence of bacterial overgrowth. Tool to be used include breath testing via gas chromatography. Specific measurements obtained hydrogen and methane in parts per million (ppm) at baseline and every 30 minutes for 2-3 hours. These outcome will only be measured once per subject and not be reassessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032262
|Contact: Tennekoon Karunaratnefirstname.lastname@example.org|
|United States, Georgia|
|Augusta University Digestive Health Research||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Tennekoon Karunaratne 706-721-8906 email@example.com|
|Principal Investigator:||Amol Sharma, MD||Augusta University|