Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine change in motor function score as assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part - III scale 1 week after the repetitive tDCS (Minimum Score 0, Maximum Score 132, higher scores indicate more disability)
研究概览
简要总结
Dopaminergic medications and Deep Brain Stimulation (DBS) are the current standards interventions for Parkinson's Disease. Pharmacotherapy with dopaminergic drugs leads to partial improvement in motor functions of patients. Invasive therapies like DBS have as yet limited availability and accessibility, with risk of adverse events as well. Non invasive therapies like Transcranial Direct Current Stimulation (tDCS) are currently increasingly being probed for their therapeutic value, in view of their safety, portability and convenience of administration.
Improvement in motor function immediately after a single session of tDCS has been observed. The effect of single simulation is not sustained beyond a few days. Only few studies with varied sites of stimulation have evaluated the effect of repetitive tDCS on motor function improvement in patients with Parkinson's Disease, with conflicting results. There is an unmet need to probe the utility of repetitive tDCS on motor function of patients with Parkinson's Disease.
We aim to probe the effect of repetitive tDCS of dorsolateral prefrontal cortex and M1 cortex on motor function in patients with Parkinson's Disease (Hoehn and Yahr stage 2 to 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the Movement Disorder Society (MDS) clinical diagnostic criteria for Parkinson's disease.
- •Patients with Hoehn & Yahr stages 2-4 Parkinson's disease.
- •Patients maintained on stable medical regimen for at least 1 month before entering the study.
排除标准
- •Patients with other confounding neurological and psychiatric disorders.
- •The presence of metal objects or stimulators in the head.
- •Patients with a history of deep brain stimulation.
- •Patients with history of seizures.
- •Patients with skull defect due to surgery e.g. craniectomy
- •Patients with scalp condition likely to obstruct application of electrodes.
研究组 & 干预措施
Anodal tDCS arm (will receive true tDCS)
Will receive true anodal tDCS stimulation
干预措施: Transcranial Direct Current Stimulation (Device)
Sham tDCS arm (will receive Sham stimulation)
Will not receive anodal tDCS stimulation
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
To determine change in motor function score as assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part - III scale 1 week after the repetitive tDCS (Minimum Score 0, Maximum Score 132, higher scores indicate more disability)
时间窗: 1 week
次要结局
- To determine the change in Timed Up and Go test score of patients with Parkinson's Disease at 1 week after the repetitive tDCS (higher times indicate disability with increased risk of fall)(1 week)
研究者
Dr Ashish Kumar Duggal
Professor, Department of Neurology, ABVIMS and Dr RML Hospital, New Delhi
Dr. Ram Manohar Lohia Hospital