Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Augusta University
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Cortical Evoked Potential (CEP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 <
- •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).
Outcomes
Primary Outcomes
Cortical Evoked Potential (CEP)
Time Frame: Single Visit, 3 hours
Bilateral amplitude (microvolts) for ano-rectal CEP responses
Motor Evoked Potential (MEP)
Time Frame: Single visit, 2 hours
Bilateral amplitude (microvolts) for ano-rectal MEP responses
Secondary Outcomes
- Non-motor symptoms questionnaire(Single visit, 1 hour)
- Stool diary(2 visits, 1 hour)
- Anal sensorimotor function(Single visit, 2 hours)
- Montreal Cognitive Assessment (MoCA)(Single visit, 1 hour)
- Gastrointestinal motor function and transit(2 visits, 1hour)
- Unified Parkinson Disease Rating Scale (UPDRS)(Single visit, 1 hour)
- 36-Item Short Form Survey (SF-36)(Single visit, 1 hour)
- Gastroparesis Cardinal Symptom Index (GCSI)(Single visit, 1 hour)
- Eckdart score (ESS)(Single visit, 1 hour)
- Rectal sensorimotor function(Single visit, 2 hours)
- Breath testing(Single visit, 3 hours)