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.
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
- Conditions the study is for
- Parkinson Disease, Constipation, Gastro-Intestinal Disorder
- 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.
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- 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
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.
- Conditions
- Parkinson Disease, Constipation, Gastro-Intestinal Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Relationship to the GI track | Other | Patients 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.
Cortical Evoked Potential (CEP)
Bilateral amplitude (microvolts) for ano-rectal CEP responses
Measured: Single Visit, 3 hours
Motor Evoked Potential (MEP)
Bilateral amplitude (microvolts) for ano-rectal MEP responses
Measured: Single visit, 2 hours
Secondary outcomes (11)
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
Rectal sensorimotor function
Rectal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Measured: Single visit, 2 hours
Anal sensorimotor function
Anal sustained squeeze pressure (mmHg) measure from Anal rectal manometry study
Measured: Single visit, 2 hours
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
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
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
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
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
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
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
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.
- First posted25 Jul 2019
- Study start4 Oct 2017
- Primary completion30 Jul 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Responsible party
- Sponsor
- Investigators
- Amol Sharma, MD, Principal investigator, Augusta University
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Gastrointestinal and Neuroenteric Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04032262
- Acronym / sponsor ID
- PARKIDF00001
- Conditions
- Parkinson Disease, Constipation, Gastro-Intestinal Disorder
- Keywords
- Brain-Gut Relationship, Anorectal Manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Relationship to the GI track | Other | Diagnostic Test: Gastrointestinal and Parkinson's DiseasePatients with Parkinson's. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal and Parkinson's DiseaseSubjects 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. | Diagnostic test | Parkinson's Disease Relationship to the GI track |
Primary outcome
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
11 secondary outcomes
Gastrointestinal motor function and transit
Time frame: 2 visits, 1hour
Rectal sensorimotor function
Time frame: Single visit, 2 hours
Anal sensorimotor function
Time frame: Single visit, 2 hours
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Single visit, 1 hour
Montreal Cognitive Assessment (MoCA)
Time frame: Single visit, 1 hour
Non-motor symptoms questionnaire
Time frame: Single visit, 1 hour
36-Item Short Form Survey (SF-36)
Time frame: Single visit, 1 hour
Stool diary
Time frame: 2 visits, 1 hour
Gastroparesis Cardinal Symptom Index (GCSI)
Time frame: Single visit, 1 hour
Eckdart score (ESS)
Time frame: Single visit, 1 hour
Breath testing
Time frame: Single visit, 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No. Parkinson's Disease foundation sponsored this study they will most likely be made aware about how recruitment went, participation, and ending results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Sharma, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
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.