Back to resultsParkinson's Disease and Digestive Health
Primary Purpose
Parkinson Disease, Constipation, Gastro-Intestinal Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastrointestinal and Parkinson's Disease
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease focused on measuring Brain-Gut Relationship, Anorectal Manometry
Eligibility 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).
Sites / Locations
- Augusta University Digestive Health Research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Parkinson's Disease Relationship to the GI track
Arm Description
Patients with Parkinson's.
Outcomes
Primary Outcome Measures
Cortical Evoked Potential (CEP)
Bilateral amplitude (microvolts) for ano-rectal CEP responses
Motor Evoked Potential (MEP)
Bilateral amplitude (microvolts) for ano-rectal MEP responses
Secondary Outcome Measures
Gastrointestinal motor function and transit
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
Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Anal sensorimotor function
Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Unified Parkinson Disease Rating Scale (UPDRS)
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)
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
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)
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
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)
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)
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
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.
Full Information
NCT ID
NCT04032262
First Posted
April 19, 2018
Last Updated
July 18, 2023
Sponsor
Augusta University
Collaborators
Parkinson's Disease Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04032262
Brief Title
Parkinson's Disease and Digestive Health
Official Title
Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
Collaborators
Parkinson's Disease Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Constipation, Gastro-Intestinal Disorder
Keywords
Brain-Gut Relationship, Anorectal Manometry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's Disease Relationship to the GI track
Arm Type
Other
Arm Description
Patients with Parkinson's.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gastrointestinal and Parkinson's Disease
Intervention Description
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 Measure Information:
Title
Cortical Evoked Potential (CEP)
Description
Bilateral amplitude (microvolts) for ano-rectal CEP responses
Time Frame
Single Visit, 3 hours
Title
Motor Evoked Potential (MEP)
Description
Bilateral amplitude (microvolts) for ano-rectal MEP responses
Time Frame
Single visit, 2 hours
Secondary Outcome Measure Information:
Title
Gastrointestinal motor function and transit
Description
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.
Time Frame
2 visits, 1hour
Title
Rectal sensorimotor function
Description
Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Time Frame
Single visit, 2 hours
Title
Anal sensorimotor function
Description
Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Time Frame
Single visit, 2 hours
Title
Unified Parkinson Disease Rating Scale (UPDRS)
Description
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).
Time Frame
Single visit, 1 hour
Title
Montreal Cognitive Assessment (MoCA)
Description
Screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A final total score of 26 and above is considered normal.
Time Frame
Single visit, 1 hour
Title
Non-motor symptoms questionnaire
Description
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.
Time Frame
Single visit, 1 hour
Title
36-Item Short Form Survey (SF-36)
Description
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.
Time Frame
Single visit, 1 hour
Title
Stool diary
Description
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.
Time Frame
2 visits, 1 hour
Title
Gastroparesis Cardinal Symptom Index (GCSI)
Description
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.
Time Frame
Single visit, 1 hour
Title
Eckdart score (ESS)
Description
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.
Time Frame
Single visit, 1 hour
Title
Breath testing
Description
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.
Time Frame
Single visit, 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol Sharma, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University Digestive Health Research
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Parkinson's Disease foundation sponsored this study they will most likely be made aware about how recruitment went, participation, and ending results.
Learn more about this trial
Parkinson's Disease and Digestive Health
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