Clinical trial NCT04032262: Parkinson's Disease and Digestive Health
Official title: Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Constipation
Gastro-Intestinal Disorder
Keywords: Brain-Gut Relationship
Anorectal Manometry
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Parkinson's Disease Foundation
First posted: 2019-07-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Cortical Evoked Potential (CEP)
timeFrame: Single Visit, 3 hours
measure: Motor Evoked Potential (MEP)
timeFrame: Single visit, 2 hours
Secondary outcomes:
measure: Gastrointestinal motor function and transit
timeFrame: 2 visits, 1hour
measure: Rectal sensorimotor function
timeFrame: Single visit, 2 hours
measure: Anal sensorimotor function
timeFrame: Single visit, 2 hours
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: Single visit, 1 hour
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Single visit, 1 hour
measure: Non-motor symptoms questionnaire
timeFrame: Single visit, 1 hour
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Single visit, 1 hour
measure: Stool diary
timeFrame: 2 visits, 1 hour
measure: Gastroparesis Cardinal Symptom Index (GCSI)
timeFrame: Single visit, 1 hour
measure: Eckdart score (ESS)
timeFrame: Single visit, 1 hour
measure: Breath testing
timeFrame: Single visit, 3 hours
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Digestive Health Research
state: Georgia
Study officials:
affiliation: Augusta University
name: Amol Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: