NCT01615718已完成不适用
Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in Motor Function
研究概览
简要总结
In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The investigators want to see if there is a difference between active and sham stimulation on these motor symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Documentation of PD diagnosis from their clinician by either a letter or verification through their medical record
- •Research criteria of "possible" or "probable" PD, as defined by Gelb et al (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39)[1]
- •Age 40 or over;
- •Taking stable medications for at least 30 days
排除标准
- •Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
- •History of deep brain stimulation or ablation surgery, mass brain lesions;
- •History of schizophrenia, schizoaffective disorder, other psychosis, episode of bipolar illness, alcohol/drug abuse within the past year;
- •Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidal;
- •Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc;
- •Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);
- •Pregnancy.
- •Epilepsy or disorders that increase likelihood of seizures including: moderate or severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolism disorders associated with seizures, and nonlacunar stroke.
结局指标
主要结局
Changes in Motor Function
时间窗: Measured for approximately 2 months
We will measure motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia tests and walking tests. We will assess the changes in these scales from baseline.
次要结局
- Safety(Measured for approximately 2 months)
- Neurophysiological Changes(Measured for approximately 2 months)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital
研究点 (2)
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