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Completed

NCT Number: NCT02749214

Defining a 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Emory Clinic Executive Park

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sample Collection

Other

Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.

Breath Sample Collection

Other

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

Defining a Parkinson's Disease (PD) -Specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2016
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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