The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of Spinal Cord Stimulation
研究概览
简要总结
The study is an open-label, prospective, single-arm, unicentral (Huashan Hospital Department of Neurology/ Neurosurgery) and exploratory clinical trial. Subjects will be enrolled from Parkinson's disease and Movement Disorder specialized outpatient department of Neurology in Huashan Hospital and network platform of chronic diseases. Spinal Cord Stimultion (SCS) will be performed in department of Neurosurgery and cerebral metabolism will be assessed in PET center of Huashan Hospital. Specialists in Neurology will follow up 3 months to record any unsafe incidents of progressive supranuclear palsy patients after the SCS surgery to evaluate safety. Meanwhile, improvement in gait disorder (including 10MWT and TUG test score) will be measured to evaluate efficacy.
详细描述
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy is an open-label, prospective, single-arm, unicentral and exploratory clinical trial.
In the screening stage, patients clinically and radiologically diagnosed as progressive supranuclear palsy with prominent gait disturbance will be enrolled. Then comprehensive evaluations and spinal cord stimulation will be performed on patients eligible for stimulation. In the subsequent process of neuromodulation, changes of clinical presentations and cerebral metabolism of participants will be assessed. Any unsafe incidents in process will be recorded in detail.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis is Progressive Supranuclear Palsy according to International Movement Disorder society criteria for Progressive Supranuclear Palsy (2017).
- •2.18FDG-PET imaging was completed within three months before the operation, and the imaging results were consistent with characteristics of Progressive Supranuclear Palsy, supporting the clinical diagnosis of Progressive Supranuclear Palsy.
- •The clinical manifestation is prominent gait balance disorder with "freezing gait", "turn difficulties" and "feet like a stick on the ground", "instabillity" and a fall history in the nearly 6 months (fall number less than or equal to 3 times).Or the researchers observe the existence of gait balance disorder, but patients can still walk without using external things with new freezing gait questionnaire survey more than 1 minute.
- •4.Those who fully understand the research and sign the informed consent.
排除标准
- •Severe mental symptoms or depression state.
- •Severe cognitive dysfunction with MMSE less than
- •Severe loss of postural reflexes (inability to stand and work independently) and depend on a walker or wheelchair.
- •Depend on nasal feeding tube.
- •Female in pregnant state when grouped.
- •Clear and definite history of neurological diseases (stroke, trauma, tumor, hydrocephalus.
- •Complicated with severe heart, liver or renal diseases.
- •Clear and definite contraindications for surgery, electrical stimulation and PET examination.
- •Unsuitable for surgery according to evaluation before the surgery.
- •Other conditions that researchers think unsuitable surgery.
- •Those who participant in other clinical trials at the same time.
结局指标
主要结局
Safety of Spinal Cord Stimulation
时间窗: 3 months
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
Efficacy of Spinal Cord Stimulation on walk time.
时间窗: 3 months after Spinal Cord Stimualtion.
Changes of the Time Up \& Go (TUG) test score. TUG test recorded the time to finish the test, the minimum time is 0 and the maximum time is 5 minutes. The longer time suggest more severe condition.
Efficacy of Spinal Cord Stimulation on walk gait.
时间窗: 3 months after Spinal Cord Stimualtion.
The change of 10 Meter Walk Test (10MWT) scores. The 10MWT recorded the time to finish the test, and the maximum time is 5 minutes. The longer time suggest more severe condition.
次要结局
- Alteration of cerebral metabolism in 18F-FDG-PET imaging(6 months)
- Alteration of gait, balance and motor score(1 month, 6 months)
研究者
Jian Wang
Professor of neurology
Huashan Hospital