The Impacts of Deep Brain Stimulation on Dual-task Gait Performance in Parkinson's Disease: Focusing on Long-term Outcome and the Effects of Stimulation Modes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Executive function - Inhibition control
研究概览
简要总结
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD
- •Age: 50~80 yrs old
- •Hoehn and Yahr stage ≤ IV after DBS operation
- •Implanted DBS system for at least 6 months
排除标准
- •Other neurological disorders
- •Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability
结局指标
主要结局
Executive function - Inhibition control
时间窗: Three days after frequency adjustment
Using the Stroop test to evaluate inhibition control
Dual-task gait performance: Stride length
时间窗: Three days after frequency adjustment
Using the OPTO gait system to evaluate stride length
Non-motor symptoms
时间窗: Every 6-month up to 2 years
Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms
Dual-task gait performance: Double limb support time
时间窗: Three days after frequency adjustment
Using the OPTO gait system to evaluate double limb support time
Executive function - Shifting attention
时间窗: Three days after frequency adjustment
Using the Trail Making Test to evaluate shifting attention
Executive function - Working memory
时间窗: Three days after frequency adjustment
Using the Digit span test to evaluate working memory
Cognitive function
时间窗: Every 6-month up to 2 years
Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
次要结局
- Usual gait performance: Double limb support time(Three days after frequency adjustment)
- Functional activity: Gait and balance performance(Every 6-month up to 2 years)
- Balance performance(Every 6-month up to 2 years)
- Motor symptoms(Every 6-month up to 2 years)
- Brain activity: Supplementary Motor Cortex(Three days after frequency adjustment)
- Brain activity: Premotor Cortex(Three days after frequency adjustment)
- Functional activity: Lower limb function(Every 6-month up to 2 years)
- Brain activity: Prefrontal Cortex(Three days after frequency adjustment)
- Parkinson's Disease patients' Quality of life(Every 6-month up to 2 years)
- Usual gait performance: Stride length(Three days after frequency adjustment)
研究者
Yea-Ru Yang
Professor
National Yang Ming Chiao Tung University
