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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30329
- The Emory Clinic Executive Park
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Unified Parkinson's Disease Rating Scale Subscale II Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Malu Tansey, PhD、Emory University
- 主任研究者：Charlene W Bayer, PhD、Hygieia, Inc
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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