Neural Control of Breathing in Parkinson's Disease: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Transcranial magnetic stimulation
研究概览
简要总结
Breathing is a complex process, which can be controlled through voluntary command or neural control. Parkinson's disease (PD) is a progressive neurological disorder. Many individuals with PD experience respiratory problems, such as coughing difficulties or shortness of breath. Changes in neural control of breathing could be part of the reason of these respiratory problems. This study will measure whether neural control of breathing is impaired in individuals with PD compared to healthy individuals.
详细描述
Rationale: Parkinson's disease (PD) is a progressive neurological disorder, characterised by loss of dopaminergic neurons. Respiratory dysfunction is common in patients with PD and can lead to pneumonia, which is a common cause of death in PD. However, the exact mechanism of respiratory dysfunction in PD is unknown. The complex process of neural control of breathing may be involved, but this is understudied. This is partly caused by methodological limitations to quantify neural control of breathing. In this study, we will use respiratory neurophysiological methods to determine whether neural control of breathing is impaired in Parkinson's disease. These techniques are hypercapnic ventilatory response, respiratory related evoked potentials and transcranial magnetic stimulation. This study will test the hypothesis that the neural control of breathing is impaired in individuals with PD compared to healthy subjects.
Objective: Primary Objective: To identify disease (Parkinson's disease) specific alterations in neural control of breathing by using respiratory neurophysiological techniques.
Study design: Exploratory cross-sectional study.
Study population: Healthy subjects (n=15) and patients with Parkinson's disease (n=15) >18 years old.
Main study parameters/endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects: competent adult (>18 years) volunteers
- •Patients: adult (<18 years) patients with Parkinson's disease, clinically confirmed by a movement disorder specialised neurologist with Hoehn and Yahr staging 1 to 3
- •Willingness and ability to understand nature and content of the study
- •Ability to participate and comply with study requirements
排除标准
- •Healthy subjects: previous or ongoing diseases of the central nervous system
- •Patients: previous or ongoing diseases of the central nervous system, other than Parkinson's disease
- •History of or current psychiatric treatment
- •History of or current brain surgery or epilepsy, unclusing deep brain stimulation
- •Neuromuscular disorders
- •Pre-existing pulmonary disease, such as chronic obstructive pulmonary disease, asthma or pulmonary fibrosis
- •TMS incompatibility (metal parts in head or neck, skin allergies)
- •Implanted cardiac pacemaker or defibrillator, neurostimulator, cochlear implant or medical infusion device
- •Large or ferromagnetic metal parts in the head (exept for a dental wire)
- •Pregnancy
结局指标
主要结局
Transcranial magnetic stimulation
时间窗: baseline - during the test
Interstimulus interval curves, using a conditioning stimulus at 80% and a test stimulus at 125%.
Respiratory related evoked potential
时间窗: baseline - during the test
A measure of cerebral cortical activity elicited by a short inspiratory occlusion, expressed in the presence, latency and amplitude of components Nf, P1, N1, P2 and P3.
Hypercapnic ventilatory response curve
时间窗: baseline - during the test
Sensitivity slope of the ventilation increase per unit increase in PetCO2, as measured with a rebreathing technique.
次要结局
- FVC(baseline - during the test)
- MIP(baseline - during the test)
- FEV1(baseline - during the test)
- MEP(baseline - during the test)