Parkinson's Disease and Digestive Health
Parkinson's Disease and Digestive Health
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.
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.
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).