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

NCT02749214 | Completed

• 1 other identifier: IRB00086732
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Up to 10 minutes

Study Arms (2)

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; 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.

Other: Blood Sample Collection; Other: Breath Sample Collection

Interventions

Blood Sample Collection OTHER

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

Healthy Control; Parkinson's Disease (PD)

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.

Healthy Control; Parkinson's Disease (PD)

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Cognitively impaired to the degree that they are not able to provide consent
• Healthy Controls
• Must be capable of providing written informed consent
• Age matched and a family member or healthy community control
• Diagnosed with cancer and/or undergoing cancer treatment.

Sponsors & Collaborators

• Emory University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

The Emory Clinic Executive Park

Atlanta, Georgia, 30329, United States

Location

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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Malu Tansey, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Charlene W Bayer, PhD

  Hygieia, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (1)