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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
Sponsor:
Collaborator:
Parkinson's Disease Foundation
Information provided by (Responsible Party):
Augusta University

Brief Summary:
This study focuses on the relationship between the brain and the gut, and additionally will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Constipation Gastro-Intestinal Disorder Diagnostic Test: Gastrointestinal and Parkinson's Disease Not Applicable

Detailed Description:
Parkinson's disease affects 1 million people in the US with a rising prevalence. In addition to neurological problems, patients with Parkinson's Disease often suffer from debilitating gastrointestinal (GI) symptoms related to delayed stomach emptying, gas/bloating, and constipation. GI complaints of patients suffering from Parkinson's Disease are poorly understood. This proposal aims to characterize GI disturbance in patients with Parkinson's Disease and provide deeper understanding by investigating symptoms, regional and whole gut transit, anorectal physiology, and the brain-gut axis. The investigator believes patients with Parkinson's Disease will show altered GI sensation, slower GI motility and demonstrate deranged regulation of the brain-gut axis correlated to severity of Parkinson's disease. Results from this study of GI motility and brain-gut axis will define a subset of Parkinson's Disease patients that can benefit from tailored treatment. This study will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Cortical Evoked Potential (CEP) [ Time Frame: Single Visit, 3 hours ]
    Bilateral amplitude (microvolts) for ano-rectal CEP responses

  2. Motor Evoked Potential (MEP) [ Time Frame: Single visit, 2 hours ]
    Bilateral amplitude (microvolts) for ano-rectal MEP responses


Secondary Outcome Measures :
  1. 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.

  2. Rectal sensorimotor function [ Time Frame: Single visit, 2 hours ]
    Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study

  3. Anal sensorimotor function [ Time Frame: Single visit, 2 hours ]
    Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Presence of 2 of 3 cardinal features of PD (resting tremor, bradykinesia, and rigidity)
  • Hoehn and Yahr Scale stage I-IV
  • Men or women aged 18+
  • Stable dopaminergic treatment for ≥4 weeks.
  • Women of childbearing potential must agree to a urine pregnancy test at screening and to avoid pregnancy throughout the study.

Exclusion Criteria:

  • Secondary parkinsonism.
  • Parkinson-plus syndromes.
  • Montreal Cognitive Assessment score <17.
  • Unstable dosage of drugs active in the cns (e.g., anxiolytics, antidepressants) during the 60 days before the visit.
  • Participation in drug studies within 30 days of screening.
  • Structural brain disease.
  • Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
  • Active or personal history of epilepsy.
  • Acute illness or active, confounding medical, neurologic, or musculoskeletal conditions.
  • Alcoholism or other forms of drug addiction.
  • Significant prior gastrointestinal surgery.
  • Ongoing chemotherapy or other treatment for cancer.
  • Dysphagia
  • implanted or externally worn medical device such as, but not limited to, a pacemaker. (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).

Information from the National Library of Medicine

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


Contacts
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Contact: Tennekoon Karunaratne 706-721-1968 tkarunaratne@augusta.edu

Locations
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United States, Georgia
Augusta University Digestive Health Research Recruiting
Augusta, Georgia, United States, 30912
Contact: Tennekoon Karunaratne    706-721-8906    tkarunaratne@augusta.edu   
Sponsors and Collaborators
Augusta University
Parkinson's Disease Foundation
Investigators
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Principal Investigator: Amol Sharma, MD Augusta University

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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT04032262     History of Changes
Other Study ID Numbers: PARKIDF00001
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Parkinson's Disease foundation sponsored this study they will most likely be made aware about how recruitment went, participation, and ending results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Augusta University:
Brain-Gut Relationship
Anorectal Manometry
Additional relevant MeSH terms:
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Digestive System Diseases
Signs and Symptoms, Digestive
Intestinal Diseases
Gastrointestinal Diseases
Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms