Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

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.
    

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.
    

Intervention name(s): Blood Sample Collection; Breath Sample Collection
Intervention type(s): Other; Other
Intervention description(s): Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.; 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.
Observational model: Case-Control
Time perspective: Prospective
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.
      
Biospecimen description: 
      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.