The Contribution of the Cerebello-thalamo-cortical Circuit to the Pathology of Non-dopaminergic Responsive Parkinson's Disease Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
研究概览
简要总结
The role of the cerebello-thalamo-cortical loop in the generation of tremor, gait impairments and postural instability has been made evident. The current study will use a Magstim Rapid 2 to deliver rTMS with the aim of modulating the activity in the vermal/paravermal region of the cerebellum, and consequently the cerebello-thalamo-cortical pathway. Analysis of the effects of an acute session of stimulation will be made to determine the therapeutic potential of the protocol. Motor symptom improvement will be assessed immediately following stimulation to detect motor symptom improvement up to one hour following stimulation, providing insight into the effectiveness of the protocol to produce benefits which outlast the period of stimulation.
Participants will each receive one session of stimulation in the ON state of medication. A pre-assessment will be performed before beginning the session and a post-assessment will be performed immediately following stimulation. There will be two groups, which will both undergo the exact same protocol, however one group will receive real stimulation, and one group will receive sham stimulation.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with idiopathic Parkinson's disease
- •ability to walk 10 metres unassisted
- •ability to stand for 5 minutes unassisted
- •understand verbal instructions in English
排除标准
- •presence of brain implants (aneurysm clips, deep brain stimulation electrodes)
- •cochlear implants
- •diagnosed with vascular Parkinson's disease
- •history or increased risk of seizure
- •severe dyskinesia of neck muscles
结局指标
主要结局
Gait (GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.)
时间窗: Immediately post stimulation, effects up to one hour
5 trials of self-paced gait on a GaitRite carpet using Zeno software to measure spatial and temporal aspects of gait.
Balance: Postural Stability Testing (quiet stance on a balance force plate)
时间窗: Immediately post stimulation, effects up to one hour
3 trials lasting 30 seconds each of quiet stance on a balance force plate, where postural deviations from a central reference point on the platform will give an overall measure of postural sway, as well as score in the medial-lateral and anterior-posterior direction
Balance: Sensory Integration Testing (modified clinical test of sensory integration on balance (m-CTSIB)
时间窗: Immediately post stimulation, effects up to one hour
In accordance with the modified clinical test of sensory integration on balance (m-CTSIB), where four trials lasting 20 seconds each measure balance during various sensory conditions: 1) eyes open, firm platform, 2) eyes closed, firm platform, 3) eyes open, foam platform, 4) eyes closed, foam platform.
Tremor: Kinesia Homeview Tablet (tremor magnitude, frequency and amplitude can be measured with wireless finger accelerometer)
时间窗: Immediately post stimulation, effects up to one hour
With the use of a wireless finger accelerometer, tremor magnitude, frequency and amplitude can be measured during the upper limb movement tasks (such as rapid alternation and pointing tasks)
次要结局
未报告次要终点