Parkinson's Disease and Digestive Health

Parkinson Disease Clinical Trial

Official title:

Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032262
• Other study ID #: PARKIDF00001
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Constipation
• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Augusta University Digestive Health Research	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	Parkinson's Disease Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Evoked Potential (CEP)	Bilateral amplitude (microvolts) for ano-rectal CEP responses	Single Visit, 3 hours
Primary	Motor Evoked Potential (MEP)	Bilateral amplitude (microvolts) for ano-rectal MEP responses	Single visit, 2 hours
Secondary	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.	2 visits, 1hour
Secondary	Rectal sensorimotor function	Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study	Single visit, 2 hours
Secondary	Anal sensorimotor function	Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study	Single visit, 2 hours
Secondary	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).	Single visit, 1 hour
Secondary	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.	Single visit, 1 hour
Secondary	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.	Single visit, 1 hour
Secondary	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.	Single visit, 1 hour
Secondary	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.	2 visits, 1 hour
Secondary	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.	Single visit, 1 hour
Secondary	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.	Single visit, 1 hour
Secondary	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.	Single visit, 3 hours