Self-administered Transcranial Direct Current Stimulation for Improving Single- and Dual-task Gait in Patients With Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Exploratory, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Timed-up and go test under dual-task condition (sec)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait 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. Dual-task performance involves a complex interplay of motor functions as well as cognitive functions such as attention and executive function. One way to potentially reduce the cost of dual-tasking and the negative effects of motor-cognitive interference is to consider improving the corresponding component, i.e., motor or cognitive function.
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 and cognitive function. Most studies have examined changes before and after a single session of stimulation, with limited research verifying the cumulative and long-term effects of tDCS. Therefore, this study aims to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with PD.
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
- Triple (Participant, Care Provider, 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 by neurologists according to the UK Parkinson's Disease Society Brain Bank criteria
- •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
- •Other neurological, orthopedic, or cardiovascular co-morbidities significantly affecting gait function
- •Uncontrolled vestibular disease, orthopedic hypotension, 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 anodal electrode is positioned in the primary motor cortex (Cz) and the cathodal 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 (Device)
Left dorsolateral prefrontal cortex
The anodal electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathodal 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 (Device)
结局指标
主要结局
Timed-up and go test under dual-task condition (sec)
时间窗: Immediate post-intervention
Timed-up and go test (sec)
时间窗: Immediate post-intervention
次要结局
- modified Attention Allocation Index (mAAI) in Timed-up and go test(Follow-up (1 month))
- Trail making test(Follow-up (1 month))
- Stroop test(Follow-up (1 month))
- Timed-up and go test (sec)(Follow-up (1 month))
- Dual-task effect (%) in Timed-up and go test(Follow-up (1 month))
- Single-leg stance test(Follow-up (1 month))
- New freezing of gait questionnaire (NFoGQ)(Follow-up (1 month))
- Geriatric depression scale (GDS)-short form(Follow-up (1 month))
- Gait parameters(Follow-up (1 month))
- Timed-up and go test under dual-task condition (sec)(Follow-up (1 month))
研究者
Han Gil Seo
Principal Investigator
Seoul National University Hospital