Spinal Cord Stimulation for Parkinsonism: a Single-center, Single-arm Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of blood pressure from baseline to 3 months post-operation
研究概览
简要总结
Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for PDS with SCS. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in Parkinsonism (PDS) patients before and after SCS treatment, and shed new light on the treatment for PDS.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of blood pressure from baseline to 3 months post-operation
时间窗: 3 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 3 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 6 months post-operation
时间窗: 6 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 6 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 9 months post-operation
时间窗: 9 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 9 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 12 months post-operation
时间窗: 12 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 12 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 18 months post-operation
时间窗: 18 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 18 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
Change of blood pressure from baseline to 24 months post-operation
时间窗: 24 months
Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 24 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.
次要结局
- Change of TUG from baseline to 6 months post-operation(6 months)
- Change of TUG from baseline to 9 months post-operation(9 months)
- Change of TUG from baseline to 12 months post-operation(12 months)
- Change of TUG from baseline to 18 months post-operation(18 months)
- Change of TUG from baseline to 24 months post-operation(24 months)
- Change of apnea hypopnea index from baseline to 3 months post-operation(3 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation(9 months)
- Change of oxygen desaturation index from baseline to 3 months post-operation(3 months)
- Change of oxygen desaturation index from baseline to 6 months post-operation(6 months)
- Change of oxygen desaturation index from baseline to 9 months post-operation(9 months)
- Change of oxygen desaturation index from baseline to 12 months post-operation(12 months)
- Change of oxygen desaturation index from baseline to 18 months post-operation(18 months)
- Change of oxygen desaturation index from baseline to 24 months post-operation(24 months)
- Change of apnea hypopnea index from baseline to 6 months post-operation(6 months)
- Change of apnea hypopnea index from baseline to 9 months post-operation(9 months)
- Change of urinary retention from baseline to 12 months post-operation(12 months)
- Change of apnea hypopnea index from baseline to 12 months post-operation(12 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation(9 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation(3 months)
- Change of apnea hypopnea index from baseline to 18 months post-operation(18 months)
- Change of apnea hypopnea index from baseline to 24 months post-operation(24 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation(3 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation(6 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation(12 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation(18 months)
- Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation(24 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation(6 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation(9 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation(12 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation(18 months)
- Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation(24 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation(3 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation(6 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation(9 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation(12 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation(18 months)
- Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation(24 months)
- Change of on-off delta heart rate variability from baseline to 3 months post-operation(3 months)
- Change of on-off delta heart rate variability from baseline to 6 months post-operation(6 months)
- Change of on-off delta heart rate variability from baseline to 9 months post-operation(9 months)
- Change of on-off delta heart rate variability from baseline to 12 months post-operation(12 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation(6 months)
- Change of on-off delta heart rate variability from baseline to 18 months post-operation(18 months)
- Change of on-off delta heart rate variability from baseline to 24 months post-operation(24 months)
- Change of length of walking during 6-minute walking test from baseline to 3 months post-operation(3 months)
- Change of length of walking during 6-minute walking test from baseline to 6 months post-operation(6 months)
- Change of length of walking during 6-minute walking test from baseline to 9 months post-operation(9 months)
- Change of length of walking during 6-minute walking test from baseline to 12 months post-operation(12 months)
- Change of length of walking during 6-minute walking test from baseline to 18 months post-operation(18 months)
- Change of length of walking during 6-minute walking test from baseline to 24 months post-operation(24 months)
- Change of time of walking during 6-minute walking test from baseline to 3 months post-operation(3 months)
- Change of time of walking during 6-minute walking test from baseline to 6 months post-operation(6 months)
- Change of time of walking during 6-minute walking test from baseline to 9 months post-operation(9 months)
- Change of time of walking during 6-minute walking test from baseline to 12 months post-operation(12 months)
- Change of time of walking during 6-minute walking test from baseline to 18 months post-operation(18 months)
- Change of time of walking during 6-minute walking test from baseline to 24 months post-operation(24 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation(3 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation(6 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation(9 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation(12 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation(18 months)
- Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation(24 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation(3 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation(12 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation(18 months)
- Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation(24 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation(3 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation(6 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation(9 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation(12 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation(18 months)
- Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation(24 months)
- Change of dysarthria symptom from baseline to 3 months post-operation(3 months)
- Change of dysarthria symptom from baseline to 6 months post-operation(6 months)
- Change of dysarthria symptom from baseline to 9 months post-operation(9 months)
- Change of dysarthria symptom from baseline to 12 months post-operation(12 months)
- Change of dysarthria symptom from baseline to 18 months post-operation(18 months)
- Change of dysarthria symptom from baseline to 24 months post-operation(24 months)
- Change of urinary retention from baseline to 3 months post-operation(3 months)
- Change of urinary retention from baseline to 6 months post-operation(6 months)
- Change of urinary retention from baseline to 9 months post-operation(9 months)
- Change of urinary retention from baseline to 18 months post-operation(18 months)
- Change of urinary retention from baseline to 24 months post-operation(24 months)
- Change of MDS-UPDRS from baseline to 3 months post-operation(3 months)
- Change of MDS-UPDRS from baseline to 6 months post-operation(6 months)
- Change of MDS-UPDRS from baseline to 9 months post-operation(9 months)
- Change of MDS-UPDRS from baseline to 12 months post-operation(12 months)
- Change of MDS-UPDRS from baseline to 18 months post-operation(18 months)
- Change of MDS-UPDRS from baseline to 24 months post-operation(24 months)
- Change of UMSARS from baseline to 3 months post-operation(3 months)
- Change of UMSARS from baseline to 6 months post-operation(6 months)
- Change of UMSARS from baseline to 9 months post-operation(9 months)
- Change of UMSARS from baseline to 12 months post-operation(12 months)
- Change of UMSARS from baseline to 18 months post-operation(18 months)
- Change of UMSARS from baseline to 24 months post-operation(24 months)
- Change of lowest oxygen saturation from baseline to 3 months post-operation(3 months)
- Change of lowest oxygen saturation from baseline to 6 months post-operation(6 months)
- Change of lowest oxygen saturation from baseline to 9 months post-operation(9 months)
- Change of lowest oxygen saturation from baseline to 12 months post-operation(12 months)
- Change of lowest oxygen saturation from baseline to 18 months post-operation(18 months)
- Change of lowest oxygen saturation from baseline to 24 months post-operation(24 months)
- Change of mean oxygen saturation from baseline to 3 months post-operation(3 months)
- Change of mean oxygen saturation from baseline to 6 months post-operation(6 months)
- Change of mean oxygen saturation from baseline to 9 months post-operation(9 months)
- Change of mean oxygen saturation from baseline to 12 months post-operation(12 months)
- Change of mean oxygen saturation from baseline to 18 months post-operation(18 months)
- Change of mean oxygen saturation from baseline to 24 months post-operation(24 months)
- Change of SCOPA-AUT from baseline to 3 months post-operation(3 months)
- Change of SCOPA-AUT from baseline to 6 months post-operation(6 months)
- Change of SCOPA-AUT from baseline to 9 months post-operation(9 months)
- Change of SCOPA-AUT from baseline to 12 months post-operation(12 months)
- Change of SCOPA-AUT from baseline to 18 months post-operation(18 months)
- Change of SCOPA-AUT from baseline to 24 months post-operation(24 months)
- Change of delta cerebral artery velocity from baseline to 3 months post-operation(3 months)
- Change of delta cerebral artery velocity from baseline to 6 months post-operation(6 months)
- Change of delta cerebral artery velocity from baseline to 9 months post-operation(9 months)
- Change of delta cerebral artery velocity from baseline to 12 months post-operation(12 months)
- Change of delta cerebral artery velocity from baseline to 18 months post-operation(18 months)
- Change of delta cerebral artery velocity from baseline to 24 months post-operation(24 months)
- Change of TUG from baseline to 3 months post-operation(3 months)