Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Gait parameters --- foot rotation [degtree]
研究概览
简要总结
Spinal cord stimulation (SCS) has proven to be effective for pain that is unresponsive to medication. This technique involves an anesthesiologist or a neurosurgeon placing stimulation electrodes at the thoracic vertebrae to provide pain relief. Although SCS is not currently a standard treatment for patients with Parkinson's disease, recent studies have shown that Parkinson's patients who experience intolerable pain and undergo SCS treatment not only experience pain relief but also show improvements in gait and other Parkinson's symptoms. Therefore, the investigators aim to use temporary, minimally invasive SCS electrodes to help patients with nrFOG (non-responsive Freezing of Gait) improve their stability and reduce their risk of falls.
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
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:40-85 years old.
- •Patients with primary Parkinson's disease who have been diagnosed by a movement disorder specialist for more than 5 years. Although they have a clear response to drugs, they have a frozen gait that cannot be controlled by drugs. Lower limb pain may be present with or without Parkinson's non-motor symptoms.
- •No other secondary gait problems.
排除标准
- •Atypical Parkinson's disease.
- •Patients with spinal cord injuries.
- •Medication-controlled frozen gait.
- •It is expected that there are lesions near the implantation area causing spinal canal stenosis or myelopathy (can be ruled out by MRI).
- •It is expected that the implantation area has undergone previous surgery or there is infection near the implantation area, which may affect the success rate of implantation or increase concerns about complications (such as severe extraspinal adhesion, or spinal cord damage in previous surgeries).
- •People with abnormal coagulation function (such as hemophilia patients) or those who have been controlled by long-term use of antithrombotic drugs and cannot stop taking them in a short period of time.
- •CDR (Clinical Dementia Rating Scale) ≧
- •Those who are allergic to developer.
结局指标
主要结局
Gait parameters --- foot rotation [degtree]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- step length [cm]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- stride length [cm]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- step width [cm]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- stance phase [%]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- swing phase [%]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- double stance phase [%]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- step time [second]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- stride time [second]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- cadence [steps/minute]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Gait parameters --- velocity [km/hour]
时间窗: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
次要结局
- Clinical score(Day 0, Day 2, Day 3, Day 4, and Day 7)
- Clinical Scale(Day 0, Day 2, Day 3, Day 4, and Day 7)