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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Malu Tansey, Emory University
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Malu Tansey, Emory University
ClinicalTrials.gov Identifier:
NCT02749214
First received: April 20, 2016
Last updated: October 21, 2016
Last verified: October 2016
  Purpose

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 Intervention
Parkinson's Disease Other: Blood Sample Collection Other: Breath Sample Collection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

Resource links provided by NLM:


Further study details as provided by Malu Tansey, Emory University:

Primary Outcome Measures:
  • 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.


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.

Estimated Enrollment: 100
Study Start Date: February 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02749214

Contacts
Contact: Malu Tansey, PhD 404-727-6126 malu.tansey@emory.edu
Contact: Elaine F Sperin 404-712-7044 esperin@emory.edu

Locations
United States, Georgia
The Emory Clinic Executive Park Recruiting
Atlanta, Georgia, United States, 30329
Contact: Malu Tansey, PhD    404-727-6126    malu.tansey@emory.edu   
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
Study First Received: April 20, 2016
Last Updated: October 21, 2016

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 25, 2017