AzTrials
AzTrials

Parkinson DiseaseNCT04032262

Parkinson's Disease and Digestive Health

A study testing Gastrointestinal and Parkinson's Disease in people with Parkinson Disease and Constipation, run by Augusta University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Gastrointestinal and Parkinson's Disease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
4 Oct 2017to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Augusta University Digestive Health Research

    Augusta, Georgia, 30912

Other trials in United States

About this study

Official title: Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease

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.

Read the 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.

Being tested
Gastrointestinal and Parkinson's Disease
Keywords
Brain-Gut Relationship, Anorectal Manometry
Medical subject headings
Parkinson Disease, Constipation, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastrointestinal and Parkinson's DiseaseDiagnostic 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.

Study groups in NCT04032262
Study groupRoleWhat they receive
Parkinson's Disease Relationship to the GI trackOtherPatients with Parkinson's.
Receives: Diagnostic Test: Gastrointestinal and Parkinson's Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cortical Evoked Potential (CEP)

    Bilateral amplitude (microvolts) for ano-rectal CEP responses

    Measured: Single Visit, 3 hours

  2. Motor Evoked Potential (MEP)

    Bilateral amplitude (microvolts) for ano-rectal MEP responses

    Measured: Single visit, 2 hours

Secondary outcomes (11)
  1. Gastrointestinal motor function and transit

    The measurements to be obtained are gastric emptying time (GET), small bowel transit time (SBTT), colonic transit time (CTT) and whole gut transit time (WGTT) over a period of 5 days. Tool to be used includes wireless motility capsule and corresponding recorder swallowed on initial visit and returned 5 days later. Specific measurements obtained include time in hours of GET, SBTT, CTT, WGTT. These outcome will only be measured once per subject and not be reassessed.

    Measured: 2 visits, 1hour

  2. Rectal sensorimotor function

    Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study

    Measured: Single visit, 2 hours

  3. Anal sensorimotor function

    Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study

    Measured: Single visit, 2 hours

  4. Unified Parkinson Disease Rating Scale (UPDRS)

    Used to follow the longitudinal course of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).

    Measured: Single visit, 1 hour

  5. Montreal Cognitive Assessment (MoCA)

    Screening assessment for detecting cognitive impairment. MoCA scores range between 0 and 30. A final total score of 26 and above is considered normal.

    Measured: Single visit, 1 hour

  6. Non-motor symptoms questionnaire

    A 30-item screening patient-based questionnaire used to determine the non-motor symptoms experienced by the patient. The points should be totalled to give a score out of 30. A score of under 10 is mild, 10-20 moderate and over 20, severe.

    Measured: Single visit, 1 hour

  7. 36-Item Short Form Survey (SF-36)

    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: Single visit, 1 hour

  8. Stool diary

    The measurement to be obtained is bowel pattern. Tool to be used include 2-week stool diary. Specific measurements obtained include number of complete spontaneous bowel movements (CSBMs) a week. These outcome will only be measured once per subject and not be reassessed.

    Measured: 2 visits, 1 hour

  9. Gastroparesis Cardinal Symptom Index (GCSI)

    The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). A six-point Likert response scale, ranging from 0 (none) to 5 (very severe), with a 2-week recall period, was used to rate the severity of each symptom. The GCSI total score was constructed as the average of the three symptom sub-scales. GCSI total scores were in the range 0-5, with higher scores reflecting greater symptom severity.

    Measured: Single visit, 1 hour

  10. Eckdart score (ESS)

    The ESS is a 4 item self-report scale measuring weight loss in kilograms, chest pain, regurgitation, and dysphagia. Each item is graded on a score of 0 to 3, with a maximum score of 12. Scores greater than or equal to 3 are considered suggestive of active achalasia. The ESS is widely used in both clinical and research settings as a gold standard for measuring achalasia symptom severity.

    Measured: Single visit, 1 hour

  11. Breath testing

    The measurement to be obtained is presence of bacterial overgrowth. Tool to be used include breath testing via gas chromatography. Specific measurements obtained hydrogen and methane in parts per million (ppm) at baseline and every 30 minutes for 2-3 hours. These outcome will only be measured once per subject and not be reassessed.

    Measured: Single visit, 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2019
  2. Study start4 Oct 2017
  3. Primary completion30 Jul 2020
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04032262
Sponsor's protocol ID
PARKIDF00001
Status last verified
Jul 2023
First submitted
19 Apr 2018
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Parkinson's Disease foundation sponsored this study they will most likely be made aware about how recruitment went, participation, and ending results.

Questions about this trial

What is this clinical trial studying?

A study testing Gastrointestinal and Parkinson's Disease in people with Parkinson Disease and Constipation, run by Augusta University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cortical Evoked Potential (CEP) (time frame: Single Visit, 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in