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临床试验/NCT05314322
NCT05314322尚未招募不适用

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

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年4月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yea-Ru Yang

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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