Defining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative Processes
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30329
- The Emory Clinic Executive Park
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
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Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
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.
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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.
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Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Unified Parkinson's Disease Rating Scale Subscale II Score
Prazo: Up to 15 minutes
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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.
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Up to 15 minutes
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Unified Parkinson's Disease Rating Scale Subscale III Score
Prazo: Up to 15 minutes
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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.
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Up to 15 minutes
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Modified Hoehn and Yahr Scale Score
Prazo: Up to 15 minutes
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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.
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Up to 15 minutes
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Overnight Questionnaire Score
Prazo: Up to 15 minutes
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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.
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Up to 15 minutes
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Beck's Depression Scale Score
Prazo: Up to 15 minutes
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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.
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Up to 15 minutes
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Montreal Cognitive Assessment (MOCA) Score
Prazo: Up to 10 minutes
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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.
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Up to 10 minutes
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Malu Tansey, PhD, Emory University
- Investigador principal: Charlene W Bayer, PhD, Hygieia, Inc
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00086732
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