Parkinsonism
Conditions
Brief summary
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.
Interventions
Epidural spinal cord stimulation (eSCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibres to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.
DEVICETranscutaneous spinal cord stimulation
Transcutaneous spinal cord stimulation (tSCS) is a non-invasive treatment that improves symptoms by stimulating spinal nerves with pulsed electrical currents via electrodes placed at corresponding spinal cord segments. The tSCS system consists of an electrical pulse stimulator, wires, and conductive patches.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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:
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of blood pressure from baseline to immediately post-operation or post transcutaneous stimulation | 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 | 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 6 months post-operation or post transcutaneous stimulation | 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 | 9 months 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 12 months post-operation or post transcutaneous stimulation | 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 18 months post-operation or post transcutaneous stimulation | 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. |
| Change of blood pressure from baseline to 24 months post-operation or post transcutaneous stimulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 oxygen desaturation index measured by on-off polysomnography from baseline to 24 months post-operation 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 measured by on-off polysomnography from baseline to immediately post-operation 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 apnea hypopnea index measured by on-off polysomnography from baseline to 3 months post-operation 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 apnea hypopnea index measured by on-off polysomnography from baseline to 6 months post-operation 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 measured by on-off polysomnography from baseline to 9 months post-operation 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 measured by on-off polysomnography from baseline to 12 months post-operation 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 measured by on-off polysomnography from baseline to 18 months post-operation 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 apnea hypopnea index measured by on-off polysomnography from baseline to 24 months post-operation 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 immediately post-operation 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 24-hour blood pressure monitoring from baseline to 3 months post-operation 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 24-hour blood pressure monitoring from baseline to 6 months post-operation 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 9 months post-operation 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 12 months post-operation 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 18 months post-operation 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 immediately post-operation 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 3 months post-operation 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 | 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 |
| 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 on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation 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 12 months post-operation 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 18 months post-operation 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 time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation 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 on-off delta serum catecholamine neurotransmitter levels from baseline to immediately post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 on-off delta serum catecholamine neurotransmitter levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 on-off length of walking during 6-minute walking test from baseline to 9 months post-operation 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 on-off delta serum catecholamine neurotransmitter levels from baseline to 6 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 on-off delta serum catecholamine neurotransmitter levels from baseline to 9 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 on-off delta serum catecholamine neurotransmitter levels from baseline to 12 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 on-off delta serum catecholamine neurotransmitter levels from baseline to 18 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 serum catecholamine neurotransmitter levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta serum catecholamine neurotransmitter levels equals the serum catecholamine neurotransmitter levels of the patient lying minus the serum catecholamine neurotransmitter levels of the patient standing up for 10 minutes. |
| 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 immediately post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 3 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 6 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 9 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 12 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 18 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 on-off delta heart rate variability from baseline to 24 months post-operation or post transcutaneous stimulation. Delta heart rate variability equals the heart rate variability of the patient lying minus the heart rate variability of the patient standing up for 10 minutes. |
| 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 on-off length of walking during 6-minute walking test from baseline to immediately post-operation 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 on-off length of walking during 6-minute walking test from baseline to 3 months post-operation 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 on-off length of walking during 6-minute walking test from baseline to 6 months post-operation 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 on-off length of walking during 6-minute walking test from baseline to 12 months post-operation 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 on-off length of walking during 6-minute walking test from baseline to 18 months post-operation 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 on-off length of walking during 6-minute walking test from baseline to 24 months post-operation 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 on-off time of walking during 6-minute walking test from baseline to immediately post-operation 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 on-off time of walking during 6-minute walking test from baseline to 3 months post-operation 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 on-off time of walking during 6-minute walking test from baseline to 6 months post-operation 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 on-off time of walking during 6-minute walking test from baseline to 9 months post-operation 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 on-off time of walking during 6-minute walking test from baseline to 12 months post-operation 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 on-off time of walking during 6-minute walking test from baseline to 18 months post-operation 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 time of walking during 6-minute walking test from baseline to 24 months post-operation 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 immediately post-operation 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 3 months post-operation 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 6 months post-operation 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 9 months post-operation 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 12 months post-operation 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 18 months post-operation 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 numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation 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 immediately post-operation 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 3 months post-operation 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 6 months post-operation 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 on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation 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 time to complete the Stroop Color and Word Test from baseline to 12 months post-operation 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 18 months post-operation 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 time to complete the Stroop Color and Word Test from baseline to 24 months post-operation 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 immediately post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 6 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 9 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 12 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 18 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation or post transcutaneous stimulation. Delta brain cortex oxygenated hemoglobin levels equals the brain cortex oxygenated hemoglobin levels of the patient lying minus the brain cortex oxygenated hemoglobin levels of the patient standing up for 10 minutes. |
| 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 measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to immediately post-operation 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 measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 3 months post-operation 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 dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 6 months post-operation 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 measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 9 months post-operation 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 measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 12 months post-operation 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 dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 18 months post-operation 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 dysarthria symptom measured by on-off Dysphonia Severity Index of Atoms Speech Assessment System from baseline to 24 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to immediately post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 3 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 6 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 9 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 12 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 18 months post-operation 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 | The change of volume of urinary retention measured by ultrasound and urodynamic study from baseline to 24 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to immediately post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 3 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 6 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 9 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 12 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 18 months post-operation 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 | The change of on-off rating of the Movement Disorders Society sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to 24 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 3 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 6 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 9 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 12 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 18 months post-operation 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 | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 24 months post-operation or post transcutaneous stimulation |
| Change of UMSARS from baseline to immediately post-operation or post transcutaneous stimulation | Immediately post surgery or post transcutaneous stimulation | The change of on- off rating of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to immediately post-operation 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 measured by on-off polysomnography from baseline to immediately post-operation 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 measured by on-off polysomnography from baseline to 3 months post-operation 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 measured by on-off polysomnography from baseline to 6 months post-operation 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 measured by on-off polysomnography from baseline to 9 months post-operation 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 measured by on-off polysomnography from baseline to 12 months post-operation 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 measured by on-off polysomnography from baseline to 18 months post-operation 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 lowest oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation 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 measured by on-off polysomnography from baseline to immediately post-operation 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 measured by on-off polysomnography from baseline to 3 months post-operation 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 measured by on-off polysomnography from baseline to 6 months post-operation 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 measured by on-off polysomnography from baseline to 9 months post-operation 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 measured by on-off polysomnography from baseline to 12 months post-operation 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 measured by on-off polysomnography from baseline to 18 months post-operation 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 mean oxygen saturation measured by on-off polysomnography from baseline to 24 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to immediately post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 3 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 6 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 9 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 12 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 18 months post-operation 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 scales for outcomes in Parkinson's disease - autonomic dysfunction from baseline to 24 months post-operation 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 on-off delta cerebral artery velocity from baseline to immediately post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 on-off delta cerebral artery velocity from baseline to 3 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation 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 on-off delta cerebral artery velocity from baseline to 9 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 on-off delta cerebral artery velocity from baseline to 12 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 on-off delta cerebral artery velocity from baseline to 18 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 on-off delta cerebral artery velocity from baseline to 24 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| Change of TUG from baseline to immediately post-operation or post transcutaneous stimulation | Immediately post surgery or post transcutaneous stimulation | Change of on-off timed up and go from baseline to immediately post-operation 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 on-off timed up and go from baseline to 3 months post-operation 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 on-off timed up and go from baseline to 6 months post-operation 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 on-off timed up and go from baseline to 9 months post-operation 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 on-off timed up and go from baseline to 12 months post-operation 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 on-off timed up and go from baseline to 18 months post-operation 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 on-off timed up and go from baseline to 24 months post-operation 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 on-off delta cerebral artery velocity from baseline to 6 months post-operation or post transcutaneous stimulation. Delta cerebral artery velocity equals cerebral artery velocity of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. |
| 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 measured by on-off polysomnography from baseline to immediately post-operation 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 measured by on-off polysomnography from baseline to 3 months post-operation 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 measured by on-off polysomnography from baseline to 6 months post-operation 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 measured by on-off polysomnography from baseline to 9 months post-operation 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 measured by on-off polysomnography from baseline to 12 months post-operation 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 oxygen desaturation index measured by on-off polysomnography from baseline to 18 months post-operation or post transcutaneous stimulation |
Countries
China
Contacts
Primary ContactJun LIU, MD, PhD
Outcome results
None listed