NCT03517059已完成不适用
Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in the neural network between patients in OFF levodopa conditions and control subjects
研究概览
简要总结
Pilot study:
- Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
- Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
- Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations
详细描述
Prospective, clinical assessment of :
- Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)
- Motor assessment using VICON gait and balance analysis
- Pulmonary functional testing in OFF and ON drug condition
- Quality of life
- Clinical neurological MDS UPDRS , N Fog questionnaire
- ENT and speech therapist evaluation in OFF and ON drug condition
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's Disease group :
- •Patients with Parkinson's Disease, who where included in the PRODYGI-1 cohort still meeting the MP criteria, Always followed in the service of neurology and pathology of the movement.
- •Pathological control group:
- •Patients suffering from Richardson syndrome.
- •Aged over 18
- •Healthy control group:
- •Age-matched (± 5 years)
- •Recruited on the basis of volunteering.
- •free from any progressive neurological pathology after clinical examination and MoCA.
排除标准
- •For all groups:
- •Pregnant or lactating woman
- •Extra-neurological severe respiratory pathology
- •Terminal heart failure
- •Contraindication to MRI
- •Refusal / withdrawal / inability to give consent
- •ENT pathology.
结局指标
主要结局
Change in the neural network between patients in OFF levodopa conditions and control subjects
时间窗: Between two evaluation visits, on average at 3 months (baseline- 3 months)
Measure evaluated by functional MRI during the realisation of a cognitive task: symbol digit modality test
次要结局
- Change in the neural network between patients in OFF-drug conditions and healthy control subjects(Between two evaluation visits, on average at 3 months (baseline- 3 months))
- Change in the neural network between OFF-drug condition and ON-drug condition in patients(Between two evaluation visits, on average at 3 months (baseline- 3 months))
- Change in the neural network between patients in OFF-drug conditions and neurological control subjects (with supra nuclear palsy)(Between two evaluation visits, on average at 3 months (baseline- 3 months))
研究者
研究点 (1)
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