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

NCT02749214 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-06-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Malu Tansey, PhD · Emory University

  • Charlene W Bayer, PhD · Hygieia, Inc

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749214 on ClinicalTrials.gov