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
- •Diagnosed with parkinsonism according to MDS clinical diagnostic criteria for Parkinson's disease
- •Aged between 50 and 80 years
- •Able and willing to follow instruction of the researcher
- •No other conditions that the researchers consider inappropriate for inclusion
排除标准
- •Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety
- •History of alcoholism
- •Non-neurological disease-related symptoms that prevent patients from participation in the study
研究组 & 干预措施
Spinal cord stimulation(SCS) implantation
Phase I:
- Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively and by the patient's feedback of the current stimulation position until the current can cover the entire area.
- An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience.
Phase II:
The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.
干预措施: Spinal cord stimulation (Device)
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 24 months post-operation(24 months)
- 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 length of walking during 6-minute walking test 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 24-hour blood pressure monitoring from baseline to 9 months post-operation(9 months)
- Change of length of walking during 6-minute walking test from baseline to 18 months post-operation(18 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 apnea hypopnea index from baseline to 12 months post-operation(12 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 3 months post-operation(3 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 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 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 6 months post-operation(6 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 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 12 months post-operation(12 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)