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
研究组 & 干预措施
Real Stimulation
Cerebellar Repetitive theta burst stimulation will be performed using a 3 pulses at 50-Hz repeated at a rate of 5-Hz; 20 trains of 10 bursts given with 8-s intervals for a total of 600 pulses. Intensity of rTMS was set at the 80% of Amplitude of Motor Threshold (RMT) obtained in the left motor cortex for each subject.
干预措施: repetitive transcranial magnetic stimulation (Device)
Sham Stimulation
The rTMS coil stimulation will be applied in the same position of the real stimulation. The Stimulation will be performed like in the real arm with the difference that the coil will be masked and thus will be inactive. The patient will hear the same sound of real stimulation, which will be only functionally inactive but will be completely performed (for the whole time of duration of stimulation)
干预措施: repetitive transcranial magnetic stimulation (Device)
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