Status:
COMPLETED
Parkinson's Disease and Digestive Health
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Parkinson's Disease Foundation
Conditions:
Parkinson Disease
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
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 info...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04032262
Start Date
October 4 2017
End Date
December 30 2021
Last Update
July 20 2023
Active Locations (1)
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1
Augusta University Digestive Health Research
Augusta, Georgia, United States, 30912