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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Georgia
-
Atlanta, Georgia, 미국, 30329
- The Emory Clinic Executive Park
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale Subscale II Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Malu Tansey, PhD, Emory University
- 수석 연구원: Charlene W Bayer, PhD, Hygieia, Inc
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Blood Sample Collection에 대한 임상 시험
-
University Hospital, Rouen아직 모집하지 않음
-
Haydarpasa Numune Training and Research Hospital완전한
-
Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국
-
Bedford Hospital NHS TrustAnglia Ruskin University알려지지 않은
-
Applied Science & Performance Institute완전한