tDCS Plus Physical Therapy for Progressive Supranuclear Palsy: a Double Blind Randomized Sham-controlled Study With Wearing Sensors Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
Objective of the study:
To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a ten cerebellar tDCS stimulations while the placebo arm will undergo sham stimulation.
Each patient will be evaluated before and after stimulation by PSP-rating scale (PSP-RS), cognitive tests and a battery of gait and movement tests using wearing sensors technology.
详细描述
Background:
There are no medical effective treatments for progressive supranuclear palsy (PSP). Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for postural instability using tDCS stimulation
Objective of the study:
To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The patient and the examiner who did the ratings were blind to the type of tDCS 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
- •probable PSP diagnosis ability to stand alone without support for at least 5 seconds ability to walk without aid for at least three meters
排除标准
- •dementia or behavioral alterations contraindications of stimulation
结局指标
主要结局
Falls
时间窗: Number of falls recorded starting from immediately after stimulation until 3 months after the end of stimulation
Number of falls will be recorded using a diary
Cognitive testing
时间窗: Changes from Baseline to immediately after stimulation
Total Z-scores of cognitive assessment (including eight tests assessing memory, executive function, attention and visual-spatial function)
PSP rating scale (PSP-RS)
时间窗: Changes from Baseline to immediately after stimulation and after 3 months
Assessment of postural instability and disability of patients (scores ranging from 0 to 100, lower scores indicate less disability)
Static Balance- area of sway
时间窗: Changes from Baseline to immediately after stimulation
The area of sway during the postural instability tasks will be assessed (unit of measure mm2)
次要结局
- Gait speed(Changes from Baseline to immediately after stimulation)
- Static Balance: wearable sensor analyses - velocity(Changes from Baseline to immediately after stimulation)
- Tinetti Balance test (TBT)(Changes from Baseline to immediately after stimulation and after 3 months)
- Activity of daily living(Changes from Baseline to immediately after stimulation)
- Turning speed(Changes from Baseline to immediately after stimulation)
研究者
Andrea Pilotto
Parkinson's disease Rehabilitation Centre
Fondazione Europea di Ricerca Biomedica Ferb Onlus