Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy: a Double Blind Cross-over Sham-controlled Study Using 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
- Short Physical Performance Battery, total time (SPPB)
研究概览
简要总结
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on postural instability in progressive supranuclear palsy using a cross-over design and wearing sensors technology
Design:
Twenty probable PSP patients with no dementia and still able to walk 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 berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), and a battery of gait and movement tests.
Static balance was assessed by 30-seconds-trials in semitandem and tandem positions with eyes open and closed 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 theta Burst repetitive Transcranial magnetic stimulation
Objective of the study:
To test the efficacy of theta burst cerebellar stimulation on postural instability in progressive supranuclear palsy using a cross-over design and wearing sensors technology
Design:
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
- •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
Short Physical Performance Battery, total time (SPPB)
时间窗: Changes from Baseline to immediately after stimulation
The short Physical performance battery included a walking test at convenient speed, a chair-rise test at convenient speed and tests of static balance including feet together, semi-tandem and tandem stance)
Static Balance tests, total time
时间窗: Changes from Baseline to immediately after stimulation
The assessment of static balance will include four tasks, in which the patient has to stand alone and maintain the position in different conditions for up to 30 seconds: tandem and semitandem positions with eyes closed and eyes open, respectively. The time of performance without falling will be assessed.
Tinetti Balance test (TBT)
时间窗: Changes from Baseline to immediately after stimulation
Assessment of postural instability (0-28, higher scores indicate better performances)
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)
Timed up and Go tests, total time (TUG)
时间窗: Changes from Baseline to immediately after stimulation
The time of performance of two timed up and go test ( one starting with the right foot, one starting with the left foot) will be assessed
次要结局
- PSP rating scale (PSP-RS)(Changes from Baseline to immediately after stimulation)
- Static Balance: wearable sensor analyses - velocity(Changes from Baseline to immediately after stimulation)
- Static Balance: wearable sensor analyses - jerk(Changes from Baseline to immediately after stimulation)
- Static Balance: wearable sensor analyses - acceleration(Changes from Baseline to immediately after stimulation)
研究者
Andrea Pilotto
parkinson's disease Rehabilitation Centre
Fondazione Europea di Ricerca Biomedica Ferb Onlus