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

14. juni 2019 oppdatert av: Malu Tansey, Emory University

Defining a Parkinson's Disease (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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • The Emory Clinic Executive Park

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: Blood Sample Collection
Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
Annen: 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.
Annen: Blood Sample Collection
Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Unified Parkinson's Disease Rating Scale Subscale II Score
Tidsramme: 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.
Up to 15 minutes
Unified Parkinson's Disease Rating Scale Subscale III Score
Tidsramme: 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.
Up to 15 minutes
Modified Hoehn and Yahr Scale Score
Tidsramme: 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.
Up to 15 minutes
Overnight Questionnaire Score
Tidsramme: 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.
Up to 15 minutes
Beck's Depression Scale Score
Tidsramme: 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.
Up to 15 minutes
Montreal Cognitive Assessment (MOCA) Score
Tidsramme: 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.
Up to 10 minutes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emory University

Samarbeidspartnere

Michael J. Fox Foundation for Parkinson's Research

Etterforskere

  • Hovedetterforsker: Malu Tansey, PhD, Emory University
  • Hovedetterforsker: Charlene W Bayer, PhD, Hygieia, Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2016

Primær fullføring (Faktiske)

1. mai 2019

Studiet fullført (Faktiske)

1. mai 2019

Datoer for studieregistrering

Først innsendt

20. april 2016

Først innsendt som oppfylte QC-kriteriene

20. april 2016

Først lagt ut (Anslag)

22. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00086732

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