Transcranial Direct Current Stimulation to Improve Dual-task Performance in Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Explorative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Cognitive dual-task interference (%) in Timed-up & go test
研究概览
简要总结
The purpose of this study is to investigate the optimal stimulation location of transcranial direct current stimulation to improve the dual-task performance in patients with Parkinson's disease.
详细描述
Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that can be used to change cortical activity. Recently, there has been growing attention on tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have reported the positive results of tDCS on motor function. However, few studies have reported the therapeutic effect of tDCS on the dual-task performance in PD. In addition, inconsistent results have been reported because tDCS protocol has been applied in various way. Therefore, this study aims to investigate an optimized stimulation site of tDCS that could improve the dual-task performance in patients with PD.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as idiopathic Parkinson's disease
- •modified Hoehn & Yahr stage 2, 2.5, or 3
排除标准
- •History of seizure
- •Metallic implants, such as cardiac pacemaker or an artificial cochlea
- •Patients with inflammation, burns, or wounds in the stimulation area
- •Parkinson's disease dementia; cut-off is < 7 of Korean-Montreal Cognitive Assessment for illiterate patients, < 13 for those educated for 0.5-3 years, < 16 for 4-6 years of education, < 19 for 7-9 years of education, and < 20 for 10 or more years of education.
- •Severe dyskinesia or severe on-off phenomenon
- •Plan to adjust medication at the time of screening
- •Sensory abnormalities of the lower extremities, other neurological or orthopedic disease affecting lower extremities, or severe cardiovascular diseases
- •Vestibular disease or paroxysmal vertigo
- •Pregnant or lactating patients
- •Other comorbidities that make it difficult to participate in this study
研究组 & 干预措施
Primary motor cortex
The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
Left dorsolateral prefrontal cortex
The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
Ventromedial prefrontal cortex
The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
Sham stimulation
The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Cognitive dual-task interference (%) in Timed-up & go test
时间窗: Immediately after a 20-minute tDCS session
Percentage of dual-task interference calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]
Physical dual-task interference (%) in Timed-up & go test
时间窗: Immediately after a 20-minute tDCS session
Percentage of dual-task interference calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]
次要结局
- Timed-up & go test (sec): physical dual-task(Immediately after a 20-minute tDCS session)
- Stroop test(Immediately after a 20-minute tDCS session)
- Trail making test(Immediately after a 20-minute tDCS session)
- Digit span test(Immediately after a 20-minute tDCS session)
- Timed-up & go test (sec): cognitive dual-task(Immediately after a 20-minute tDCS session)
- Timed-up & go test (sec): single task(Immediately after a 20-minute tDCS session)
研究者
Han Gil Seo
Associate Professor
Seoul National University Hospital