Parkinson's Disease and Digestive Health

NCT04032262 | Completed FDA Device

• 1 other identifier: PARKIDF00001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Constipation; Gastro-Intestinal Disorder

Keywords

Brain-Gut Relationship; Anorectal Manometry

Outcome Measures

Primary Outcomes (2)

• Cortical Evoked Potential (CEP)

  Bilateral amplitude (microvolts) for ano-rectal CEP responses

  Single Visit, 3 hours

• Motor Evoked Potential (MEP)

  Bilateral amplitude (microvolts) for ano-rectal MEP responses

  Single visit, 2 hours

Secondary Outcomes (11)

• Gastrointestinal motor function and transit

  2 visits, 1hour

• Rectal sensorimotor function

  Single visit, 2 hours

• Anal sensorimotor function

  Single visit, 2 hours

• Unified Parkinson Disease Rating Scale (UPDRS)

  Single visit, 1 hour

• Montreal Cognitive Assessment (MoCA)

  Single visit, 1 hour

Study Arms (1)

Parkinson's Disease Relationship to the GI track

OTHER

Patients with Parkinson's.

Diagnostic Test: Gastrointestinal and Parkinson's Disease

Interventions

Gastrointestinal and Parkinson's Disease DIAGNOSTIC_TEST

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.

Parkinson's Disease Relationship to the GI track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Augusta University: lead
• Parkinson's Disease Foundation: collaborator

Study Sites (1)

Augusta University Digestive Health Research

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Constipation; Digestive System Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amol Sharma, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: July 25, 2019
• Study Start: October 4, 2017
• Primary Completion: July 30, 2020
• Study Completion: December 30, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)