Cerebellar rTMS Theta Burst for Dual-task Walking in Parkinson's Disease:a Double Blind Cross-over Sham-controlled Study Using Wearing Sensors Technology
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gait speed in dual-task walking
研究概览
简要总结
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on dual task walking in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Twenty Parkinson's disease patients with no dementia will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
Each patient will be evaluated before and after stimulation by a battery of gait and movement tests using wearing sensors technology .
详细描述
There are no medical effective treatments for dual-task gait in Parkinson's disease. Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for dual-task walking for theta Burst repetitive Transcranial magnetic stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on gait in Parkinson's disease using a cross-over design and wearing sensors technology
Design:
Parkinson's disease patients able to walk and without dementia/behavioral disturbances will be recruited for a cross-over sham-controlled study. Each patient will undergo a sham stimulation or a single session of cerebellar theta burst stimulation with a wash out period of at least 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The patient and the examiner who administered the clinical scales were blind to the type of rTMS delivered, which was applied by another blinded experimenter.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established Parkinson's disease
- •ability to stand alone and walk without support
排除标准
- •dementia or behavioral alterations
- •contraindication to stimulation
结局指标
主要结局
Gait speed in dual-task walking
时间窗: Changes from Baseline to immediately after stimulation
Gait speed will be assessed in normal, cognitive/motor dual-task conditions
Step variability in dual-task walking
时间窗: Changes from Baseline to immediately after stimulation
Step variability will be assessed in normal, cognitive/motor dual-task conditions walking
Step length in dual-task walking
时间窗: Changes from Baseline to immediately after stimulation
Step length will be assessed in normal, cognitive/motor dual-task conditions
次要结局
- Turning speed in timed up and go tests(Changes from Baseline to immediately after stimulation)
- total distance of dual-task walking(Changes from Baseline to immediately after stimulation)
研究者
Andrea Pilotto
Parkinson's disease Rehabilitation Centre
Fondazione Europea di Ricerca Biomedica Ferb Onlus