临床试验/NCT07322458

NCT07322458尚未招募不适用

The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms

Ruijin Hospital1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新: 2026年1月9日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Ruijin Hospital
入组人数: 40
试验地点: 1
主要终点: Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Parkinson's disease (PDS) is a syndrome characterized by tremor, bradykinesia, rigidity, and postural disturbances. Causes include Parkinson's disease (PD), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). Non-motor symptoms of PDS, such as neurogenic orthostatic hypotension (nOH), have received more intensive research due to their greater disabling potential compared to motor symptoms. In patients with PD and MSA, nOH can lead to intolerance to medications such as levodopa, significantly increasing the risk of falls, accelerating cognitive decline, and increasing the risk of all-cause mortality. However, conventional pharmacological treatments (such as midodrine, droxidopa, and fludrocortisone) and non-pharmacological approaches (such as compression abdominal bands, elastic stockings, and deep brain stimulation) for non-motor symptoms such as nOH have numerous limitations, including short-term efficacy, uncertain efficacy, and side effects. Therefore, exploring new non-pharmacological treatments to improve nOH and delay disease progression in patients with PDS is crucial for improving their quality of life and prognosis.

Spinal cord stimulation (SCS), including invasive (epidural) spinal cord stimulation (eSCS) and non-invasive (transcutaneous) spinal cord stimulation (tSCS), is a novel neuromodulatory technique with clinical applications in a variety of neurological diseases. Currently, several small-sample studies have suggested the potential efficacy of SCS for nOH caused by spinal cord injury (SCI). This study innovatively proposes the use of eSCS and tSCS to improve nOH and related clinical symptoms in patients with PDS. A prospective, single-center, randomized, controlled clinical trial is planned to compare the efficacy of invasive and non-invasive SCS in treating nOH, thereby providing new insights for the effective treatment of PDS.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 40 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•1. Aged between 40 and 80 years;
•2. No dementia as measured by the cMMSE scale (formal cMMSE score should be >20 for subjects with 1 to 6 years of formal education; cMMSE score should be >24 for subjects with >6 years of formal education);
•3. Able and willing to follow instruction of the researcher;
•4. No other conditions that the researchers consider inappropriate for inclusion:

排除标准

•1. Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety;
•2. Pregnancy;
•3. History of alcoholism;
•4. No skin abnormalities;
•5. Non-neurological disease-related symptoms that prevent patients from participation in the study.

结局指标

主要结局

Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation

时间窗: 24 months post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 24 months post-operation or post-stimulation. 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 immediately post-operation or post transcutaneous stimulation

时间窗: Immediately post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to immediately post-operation or post-stimulation. 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 3 months post-operation or post transcutaneous stimulation

时间窗: 3 months post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 3 months post-operation or post-stimulation. 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 or post transcutaneous stimulation

时间窗: 12 months post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 12 months post-operation or post-stimulation. 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 or post transcutaneous stimulation

时间窗: 6 months post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 6 months post-operation or post-stimulation. 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 or post transcutaneous stimulation

时间窗: 9 months post surgery or post transcutaneous stimulation

Change of blood pressure from baseline to 18 months post-operation or post transcutaneous stimulation

时间窗: 18 months post surgery or post transcutaneous stimulation

Changes of on-off delta systolic and delta diastolic blood pressure from baseline to 18 months post-operation or post-stimulation. 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 on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of length of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of time of walking during 6-minute walking test from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of dysarthria symptom from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of urinary retention from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of MDS-UPDRS from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of UMSARS from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of lowest oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of mean oxygen saturation from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of SCOPA-AUT from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of TUG from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of oxygen desaturation index from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 9 months post-operation or post transcutaneous stimulation(9 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of apnea hypopnea index from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation or post transcutaneous stimulation(12 months post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation or post transcutaneous stimulation(18 months post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation or post transcutaneous stimulation(24 months post surgery or post transcutaneous stimulation)
Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to immediately post-operation or post transcutaneous stimulation(Immediately post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation or post transcutaneous stimulation(3 months post surgery or post transcutaneous stimulation)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation or post transcutaneous stimulation(6 months post surgery or post transcutaneous stimulation)

研究者

发起方

Ruijin Hospital

申办方类型

Other

责任方

Sponsor

研究点 (1)

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