Investigating Neural Biomarkers for Gait in Parkinson's Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Electromyography (Delsys®) of the healthy and Parkinson patients
研究概览
简要总结
This observational study's main goal is to learn more about the neural mechanisms during movement in Parkinson's disease. Furthermore, it aims to inspire personalised treatment options.
Participants will undergo a protocol that involves walking and gait-related motor tasks, such as seated stepping. During the protocol, brain activity will be recorded.
详细描述
Parkinson's Disease (PD) is the second most common neurodegenerative disease accompanied by motor impairment [1]. Although symptomatic treatments like medication with Dopamine equivalents and deep brain stimulation (DBS) are available, the effects are very heterogeneous among patients and often cease over time.
This study aims to generate insights into the neural mechanisms of PD by determining neural biomarkers for gait. The insights of this study may further inspire personalised treatment approaches.
The primary objective is to identify neural biomarkers for gait. It is hypothesised that characteristic neural oscillations are underlying kinematic patterns in healthy participants and PD patients.
The secondary objective is to compare the neural activity during gait and a seated lower limb motor task between healthy participants and PD patients. To this end, the investigators hypothesise that neural correlates of gait and of a seated lower limb motor task differ between healthy participants and PD patients.
60 participants will be included, 30 healthy participants and 30 PD patients. All participants must be older than 18 years and give informed consent. Potential participants will be pre-screened and will be informed about the study via phone call/email. Before any study procedure, participants will give informed consent as documented by signature. Afterwards, inclusion/exclusion criteria, medical history and participant characteristics will be assessed. PD patients must be of postural instability and gait difficulty sub-type.
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
- •All participants
- •must have given informed consent as documented by signature
- •agree to comply with the study procedures
- •Healthy control group
- •no neurological, orthopedic, or rheumatologic disease history
- •no identified sensory impairment.
- •no epilepsy and self-diagnosed acute or chronic psychiatric disorders
- •Parkinson's Patients
- •non-tremor dominant idiopathic PD patients
- •presence of postural instability (UPDRS >1 for postural instability [17]), gait disturbance, and absence of other causes of reduced balance
- •Implanted with Percept™ PC neurostimulator
- •Able to be in the stimulation OFF
排除标准
- •Relevant cognitive impairment, with a score on Montréal Cognitive Assessment (MoCA) < 20
- •History of physical or neurological condition that interferes with study procedures
- •Social and/or personal circumstances interfering with the ability to come to the session
结局指标
主要结局
Electromyography (Delsys®) of the healthy and Parkinson patients
时间窗: 30 minutes
Electrodes will be attached to a representative lower limb muscle, such as the tibialis anterior.
Cortical activity underlying kinematic gait patterns will be recorded by electroencephalograph of the healthy and Parkinson patients
时间窗: 30 minutes
Using a mobile EEG system to measure neural activity during walking
Detect onset of task-related movements detected by an accelerometer that will be placed on the hand and foot of the healthy and the parkinson patients
时间窗: 30 minutes
ZurichMOVE® detects onset of movements
次要结局
- Compare cortical activity between healthy subjects and parkinson patients(30 minutes)