Selective Modulation of Cognitive, Affective, and Motor Function by Transcranial Direct Current Stimulation as Co-adjuvant Therapy in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Evidence of improvement in general motor functioning in patients with Parkinson's.
研究概览
简要总结
The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease.
In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.
详细描述
Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone)
* Further study details are provided by Spaulding Rehabilitation Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
- •Age 40 or over;
- •Taking stable medications for at least 30 days
排除标准
- •Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
- •History of deep brain stimulation or ablation surgery, mass brain lesions;
- •History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
- •Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
- •Contraindications to tDCS*
- •metal in the head
- •implanted brain medical devices
- •Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease)
- •Pregnancy
结局指标
主要结局
Evidence of improvement in general motor functioning in patients with Parkinson's.
时间窗: after treatment (10 days) and at follow up (1 and 2 months after final stimulation)
Measured by various indexes, including Unified Parkinson's Disease Rating Scale (UPDRS), Simple Reaction Time, 4-Choice Reaction Time, Purdue Pegboard Test, Finger tapping, walking time, buttoning up and supination-pronation.
次要结局
- Evidence of improvement in cognitive functioning in the areas of: executive function, reasoning, visuospatial ability, and working memory for patients with Parkinson's.(after treatment (10 days) and at follow up (1 and 2 months after final stimulation))
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital