An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- RBD Screening Questionnaire
研究概览
简要总结
To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.
详细描述
Rapid eye movement sleep behavior disorder (RBD) is one of the most common accompanying symptoms of Parkinson's disease (PD). PD-RBD patients have more severe clinical manifestations, require larger drug doses, and have more non-motor symptoms. Although several strategies using transcranial direct current stimulation (tDCS) have been investigated for the treatment of sleep disorders, the efficacy of high-definition tDCS (HD-tDCS) in PD-RBD patients remains unclear.
We conducted an open-label study using the RBD-SQ to identify individuals with possible RBD (pRBD), and recruiting the patients at the First Affiliated Hospital of Anhui Medical University to receive cathodal HD-tDCS intervention. On the basis of conventional anti-PD drugs, cathodal HD-tDCS treatment was performed on the left M1 area once a day for 20 minutes, and the treatment was continued for 10 days. The International Movement Disorders Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the Hoehn & Yahr staging scale (H&Y), REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), RBD Screening Questionnaire Hong Kong (RBDSQ- HK), Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), and Parkinson disease sleep scale (PDSS) were assessed on intervention Day 1 and Day 10, and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of PD was determined by neurologists with rich clinical work experience, and was in line with the diagnostic criteria for Parkinson's disease in China (2016 edition).
- •The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.
- •All patients took the drug stably and had no history of drug adjustment within 2 months before treatment. The test was conducted 2 hours after taking the drug.
- •Good compatibility, with a certain degree of compliance;
- •Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;
排除标准
- •The patient has a metal object or skull brace device or any similar metal object on the scalp;
- •Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;
- •The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);
- •Have a head injury, stroke or other neurological disorder;
- •The diagnosis of PD dementia is difficult to complete the assessment.
研究组 & 干预措施
tDCS group
a course of tDCS treatment is performed for 10 days
干预措施: transcranial Direct Current Stimulation (Behavioral)
结局指标
主要结局
RBD Screening Questionnaire
时间窗: baseline; day 10
The RBD Screening Questionnaire (RBDSQ) is the most widely used tool over the past decade and includes 13 yes-or-no questions regarding the presence of move- ments and dream-enacting behaviours during sleep(maximum total score 13 points) .
次要结局
- REM sleep behavior disorder questionnaire-Hong Kong(baseline; day 10)
- Pittsburgh sleep quality index(baseline; day 10)
- EPworth Sleepiness Scale(baseline; day 10)
- Parkinson disease sleep scale(baseline; day 10)
- Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale(baseline; day 10)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University