Mapping Functional Networks of Brain Activity (Brain Network Activation, BNA) Based on Analysis of Evoked Response Potential (ERP) Signals for Healthy Controls Evoked Response Potential (ERP) Signals for Healthy Controls and Patients With Parkinson Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential
研究概览
简要总结
A cornerstone in PD research is the investigation of neurophysiological changes as potential biomarkers that could help in tracking disease progression and response to therapies. Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for identification of such biomarkers. In this study we will use high-density electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that could be more sensitive and reliable to disease progression and response to therapeutic intervention than standard clinical measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic PD patients (according to the UK PD Society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no atypical features or secondary cause) and HC aged 40-80 years
- •PD patients Hoehn and Yahr stages I to IVStable PD therapy
排除标准
- •In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
- •Patients or HC with significant psychiatric symptoms or history
- •BDI score <14
- •MMSE <25
- •Treatment with neuroleptics.
- •For PD patients: Hoehn and Yahr Stage 5
- •PD Patients with severe dyskinesia or tremor
- •PD Patients with atypical Parkinsonism or secondary Parkinsonism
- •History or evidence of neurological problems: cerebrovascular disease, previous head injury or neurosurgical interventions.
- •Currently with lice or open wounds on scalp.
- •Significant sensory deficits, e.g., deafness or blindness
- •Current drug abuse or alcoholism.
- •Pregnancy or not using a reliable method of birth control.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
结局指标
主要结局
Functional networks of brain activity in Idiopathic PD patients and healthy individuals measured using analysis of EEG Event Related Potential
时间窗: 2 WEEKS
The study outcome measure are functional networks of brain activity of PD patients and healthy individuals established based on an analysis of EEG data recorded while study subjects perform ERP tasks
次要结局
未报告次要终点
研究者
Dr. Oren Cohen
MD
Sheba Medical Center