Parkinson's DiseaseNCT02749214
Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
An observational study of Parkinson's Disease, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory… Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Blood Sample Collection and Breath Sample Collection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2019
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with a clinical diagnosis of Parkinson's Disease Hohn \& Yahr Stages 1 and 2 will be recruited from the Emory Movement and Disorders Clinic. Age and sex-matched healthy controls will also be recruited.
Who may be able to join
- Must be capable of providing written informed consent
- Non-smoking
- Clinical diagnosis of PD Hohn \& Yahr Stages 1 and 2
- Must be capable of providing written informed consent
- Age matched and a family member or healthy community control
Who cannot join
- Cognitively impaired to the degree that they are not able to provide consent
- Healthy Controls
- Diagnosed with cancer and/or undergoing cancer treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Emory Clinic Executive Park
Atlanta, Georgia, 30329
About this study
Official title: Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.
The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.
Read the detailed description
The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.
The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.
Investigators will determine how molecules in human breath can define a "breath signature" that can be associated with neurological disorders like Parkinson's disease. The long-term goal of this study is to use blood inflammatory marker relationships and Breath Analytical Approach to identify individuals at risk for development of neurologic disorders and to monitor the effects of immune interventions on the rate of disease progression.
The study team will recruit a total of 100 participants: 50 early stage (defined by a Hohn \& Yahr Stages 1-2), non-smoking Parkinson's Disease patients from among the Emory Movement Disorders Clinic and 50 age and sex-matched healthy controls (HC). Investigators will recruit six to eight participants per month over an 18-month time period.
- Conditions
- Parkinson's Disease
- Being tested
- Blood Sample Collection, Breath Sample Collection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
Breath Sample CollectionOther
Participants will be asked to breathe into the Breath Sampler containing a rapid passive volatile organic compounds (VOC) sampling device. A disposable mouthpiece is placed over a portion of the sampler where the participant placed his/her mouth. The mouthpiece will be disposed of after each use and a new one will be used for each participant. Prior to sample collection, the participant will be asked to rinse his/her mouth with water. Then the participant will breathe deeply into the sampler five times with breaths being five minutes apart to collect the alveolar breath.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease (PD) | Participant's with Parkinson's Disease will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires. Receives: Other: Blood Sample Collection; Other: Breath Sample Collection | |
| Healthy Control | Age and gender-matched healthy controls will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires. Receives: Other: Blood Sample Collection; Other: Breath Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale Subscale II Score
The Unified Parkinson's Disease Rating Scale Subscale II is a measure of self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food. Items are rated from 0 (normal) to 4 (severe). A higher total score indicates more severe disease.
Measured: Up to 15 minutes
Unified Parkinson's Disease Rating Scale Subscale III Score
The Unified Parkinson's Disease Rating Scale Subscale III is a clinician-scored monitored motor evaluation. Items are rated from 0 (normal) to 4 (severe). A higher total score indicates more severe disease.
Measured: Up to 15 minutes
Modified Hoehn and Yahr Scale Score
The Modified Hoehn and Yahr Scale is used to describe how the symptoms of Parkinson's disease progress. Stages of disease range from 1 to 5 where 5 is the most severe.
Measured: Up to 15 minutes
Overnight Questionnaire Score
The Overnight Questionnaire is completed by a person living with the participant with Parkinson's Disease. Questions refer to behaviors witnessed during sleep. Questions are answered on a scale from 1 (never) to 4 (always). A higher score indicates more symptoms of sleep disruption.
Measured: Up to 15 minutes
Beck's Depression Scale Score
The Beck's Depression Scale is a 21 one item scale used to describe how a participant has been feeling over the past two weeks. A total score between 0-21 indicates very low anxiety. A between 22-35 indicates moderate anxiety. A score that exceeds 36 indicates high anxiety.
Measured: Up to 15 minutes
Montreal Cognitive Assessment (MOCA) Score
The Montreal Cognitive Assessment (MOCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Malu Tansey, Emory University
- Investigators
- Malu Tansey, PhD, Principal investigator, Emory UniversityCharlene W Bayer, PhD, Principal investigator, Hygieia, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749214
- Sponsor's protocol ID
- IRB00086732
- Status last verified
- Jun 2019
- First submitted
- 20 Apr 2016
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
- ClinicalTrials.gov ID
- NCT02749214
- Acronym / sponsor ID
- IRB00086732
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.
The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.
Detailed description
The purpose of this study is to determine the potential for a Parkinson's Disease (PD) -specific breath signature as a non-invasive screening tool for identifying PD patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. Neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions.
The study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. Investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.
Investigators will determine how molecules in human breath can define a "breath signature" that can be associated with neurological disorders like Parkinson's disease. The long-term goal of this study is to use blood inflammatory marker relationships and Breath Analytical Approach to identify individuals at risk for development of neurologic disorders and to monitor the effects of immune interventions on the rate of disease progression.
The study team will recruit a total of 100 participants: 50 early stage (defined by a Hohn \& Yahr Stages 1-2), non-smoking Parkinson's Disease patients from among the Emory Movement Disorders Clinic and 50 age and sex-matched healthy controls (HC). Investigators will recruit six to eight participants per month over an 18-month time period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | – | Other: Blood Sample Collection, Other: Breath Sample CollectionParticipant's with Parkinson's Disease will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires. |
| Healthy Control | – | Other: Blood Sample Collection, Other: Breath Sample CollectionAge and gender-matched healthy controls will provide peripheral blood and breath samples. Participants will also be asked to complete a neurologic exam and questionnaires. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a clinical diagnosis of Parkinson's Disease Hohn \& Yahr Stages 1 and 2 will be recruited from the Emory Movement and Disorders Clinic. Age and sex-matched healthy controls will also be recruited.
Key inclusion criteria (5 listed)
- Must be capable of providing written informed consent
- Non-smoking
- Clinical diagnosis of PD Hohn \& Yahr Stages 1 and 2
- Must be capable of providing written informed consent
- Age matched and a family member or healthy community control
Key exclusion criteria (3 listed)
- Cognitively impaired to the degree that they are not able to provide consent
- Healthy Controls
- Diagnosed with cancer and/or undergoing cancer treatment.
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 |
|---|---|---|
| Blood Sample CollectionParticipants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers. | Other | Healthy Control, Parkinson's Disease (PD) |
| Breath Sample CollectionParticipants will be asked to breathe into the Breath Sampler containing a rapid passive volatile organic compounds (VOC) sampling device. A disposable mouthpiece is placed over a portion of the sampler where the participant placed his/her mouth. The mouthpiece will be disposed of after each use and a new one will be used for each participant. Prior to sample collection, the participant will be asked to rinse his/her mouth with water. Then the participant will breathe deeply into the sampler five times with breaths being five minutes apart to collect the alveolar breath. | Other | Healthy Control, Parkinson's Disease (PD) |
Primary outcome
Unified Parkinson's Disease Rating Scale Subscale II Score
Time frame: Up to 15 minutes
The Unified Parkinson's Disease Rating Scale Subscale II is a measure of self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food. Items are rated from 0 (normal) to 4 (severe). A higher total score indicates more severe disease.
Unified Parkinson's Disease Rating Scale Subscale III Score
Time frame: Up to 15 minutes
The Unified Parkinson's Disease Rating Scale Subscale III is a clinician-scored monitored motor evaluation. Items are rated from 0 (normal) to 4 (severe). A higher total score indicates more severe disease.
Modified Hoehn and Yahr Scale Score
Time frame: Up to 15 minutes
The Modified Hoehn and Yahr Scale is used to describe how the symptoms of Parkinson's disease progress. Stages of disease range from 1 to 5 where 5 is the most severe.
Overnight Questionnaire Score
Time frame: Up to 15 minutes
The Overnight Questionnaire is completed by a person living with the participant with Parkinson's Disease. Questions refer to behaviors witnessed during sleep. Questions are answered on a scale from 1 (never) to 4 (always). A higher score indicates more symptoms of sleep disruption.
Beck's Depression Scale Score
Time frame: Up to 15 minutes
The Beck's Depression Scale is a 21 one item scale used to describe how a participant has been feeling over the past two weeks. A total score between 0-21 indicates very low anxiety. A between 22-35 indicates moderate anxiety. A score that exceeds 36 indicates high anxiety.
Montreal Cognitive Assessment (MOCA) Score
Time frame: Up to 10 minutes
The Montreal Cognitive Assessment (MOCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
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 18 Jun 2019.
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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.
Malu Tansey, PhD principal investigator
Emory University
Charlene W Bayer, PhD principal investigator
Hygieia, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Emory 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 3 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 18 Jun 2019. 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?
Unified Parkinson's Disease Rating Scale Subscale II Score (time frame: Up to 15 minutes). The study lists 6 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 18 Jun 2019.