Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

• ClinicalTrials.gov Identifier: NCT02749214
• Recruitment Status: Completed
• First Posted: April 22, 2016
• Last Update Posted: June 18, 2019
• Sponsor: Emory University
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Information provided by (Responsible Party): Malu Tansey, Emory University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment
Parkinson's Disease	Other: Blood Sample Collection; Other: Breath Sample Collection

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

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: May 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: Blood Sample Collection; Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.; Other: Breath Sample Collection; 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.
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.	Other: Blood Sample Collection; Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.; Other: Breath Sample Collection; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Biospecimen Retention:   Samples Without DNA

Breath samples will be collected to analyze for breath volatile organic compounds (BVOC). Peripheral blood samples will also be collected and analyzed for inflammatory proteins.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

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.

Criteria

Participants with Parkinson's Disease (PD)

Inclusion Criteria:

• Must be capable of providing written informed consent
• Non-smoking
• Clinical diagnosis of PD Hohn & Yahr Stages 1 and 2

Exclusion Criteria:

• Cognitively impaired to the degree that they are not able to provide consent

Healthy Controls

Inclusion Criteria:

• Must be capable of providing written informed consent
• Age matched and a family member or healthy community control

Exclusion Criteria:

• Diagnosed with cancer and/or undergoing cancer treatment.

Contacts and Locations

Locations

United States, Georgia

The Emory Clinic Executive Park

Atlanta, Georgia, United States, 30329

Sponsors and Collaborators

Emory University

Michael J. Fox Foundation for Parkinson's Research

Investigators

• Principal Investigator: Malu Tansey, PhD; Emory University
• Principal Investigator: Charlene W Bayer, PhD; Hygieia, Inc

More Information

• Responsible Party: Malu Tansey, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02749214 History of Changes
• Other Study ID Numbers: IRB00086732
• First Posted: April 22, 2016
• Last Update Posted: June 18, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases