Sensor-Driven Position-Adaptive Spinal Cord Stimulation for Treatment of Gait Disturbance in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- 6-min walk test during the second week (6MWT-2W)
研究概览
简要总结
Spinal cord stimulation (SCS) has been suggested by several research for treating PD gait disturbance. However, the side effects induced by body position change cannot fully addressed by conventional SCS. Medtronic sensor-driven position-adaptive SCS are capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects. Nevertheless, neither the efficacy nor safety of this technique in the treatment of gait disturbance in PD is ever investigated. Therefore, the investigators will conduct a randomized clinical trial to investigate the clinical efficacy and safety of sensor-driven position-adaptive SCS in the treatment of gait disturbance in PD. This study will contribute to find out the safety and efficacy of sensor-driven position-adaptive SCS in the treatment of PD gait disorder, improve patients' quality of life, and reduce the burden on family and society.
详细描述
The study is a randomized double-blind crossover design aiming to test the short-term efficacy and safety of sensor-driven position-adaptive SCS in the treatment of gait disturbance in patients with PD. More than 1 month after operation, subjects will be randomly assigned into two groups, with one group treated with conventional spinal cord stimulation intervention and the other treated with sensor-driven position-adaptive spinal cord stimulation intervention. Both groups will be followed-up for more than 1 week and receive comprehensive evaluation. A cross-over design will then be applied to eliminate the individual variability until both groups complete another 1 week follow-up. Stimulation parameters and levodopa equivalent daily dose (LEDD) remained during follow-up in both group. Clinical evaluation is assessed by 6-min walk test (6MWT) and timed up-and-go task (TUG) with gait analysis. Quality of life is evaluated by The 5-level EQ-5D. The severity of PIGD is assessed by gait and fall questionnaire (GFQ) , modified fall efficacy scale(MFES), activities-specific balance confidence (ABC) scale and the survey of activities and fear of falling in the elderly (SAFFE ). Within group t test will be made for comparison between two groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1,Parkinsonism(including idiopathic Parkinson's disease,Vascular Parkinson's disease, Atypical parkinsonism).
- •2, Aged 45-75 years old, Hoehn & Yahr stage (medication off condition) at 2~4;
- •3, Patients willingly seek surgical treatment for PD gait disturbance；
- •4, Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy;
- •5, SCS eligibility has been confirmed by neurologist and neurosurgeon;
- •6, Ability to perform a gait/walking task (under close supervision);
- •7, Informed consent and have good compliance.
排除标准
- •1, Lesion in spinal cord or other surgical contraindications;
- •2, Other neuropsychiatric disorders or relevant medical history; haven't achieved the optimal therapeutic effects of DBS surgery or drug therapy;
- •3, Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis; taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.);
- •4, Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;
- •5, Women reporting that they are pregnant;
- •6, Any situation (medical, psychological, social, geographical, etc.) that may endanger patient's life or result in patients withdrawing from the study at present or in the future.
研究组 & 干预措施
conventional SCS
干预措施: conventional SCS (Device)
sensor-driven position-adaptive SCS
干预措施: sensor-driven position-adaptive SCS (Device)
结局指标
主要结局
6-min walk test during the second week (6MWT-2W)
时间窗: 2 week follow-up
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
timed up-and-go task during the second week (TUG-2W)
时间窗: 2 week follow-up
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
6-min walk test during the first week (6MWT-1W)
时间窗: 1 week follow-up
The 6-min walk test is a test walking over a span of 6 minutes. Gait characters are recorded for further analysis.
timed up-and-go task during the first week (TUG-1W)
时间窗: 1 week follow-up
The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. Gait characters are recorded for further analysis.
次要结局
- Modified Fall Efficacy Scale(MFES)(1 and 2 week follow-up)
- Gait and Fall Questionnaire(GFQ)(1 and 2 week follow-up)
- Survey of Activities and Fear of Falling in the Elderly (SAFFE )(1 and 2 week follow-up)
- EuroQol 5-Dimension, 5-Level Health Scale(EQ-5D-5L)(1 and 2 week follow-up)
- Activities-specific Balance Confidence (ABC) scale(1 and 2 week follow-up)
研究者
Bomin Sun
Head of Stereotactic and Functional Neurosurgery, Principal Investigator, Clinical Professor
Ruijin Hospital