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The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms
Sponsor: Ruijin Hospital
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.
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-01-01
Completion Date
2028-06-30
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
Epidural spinal cord stimulation
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.
Transcutaneous 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.
Locations (1)
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025 Recruiting
Shanghai, Shanghai Municipality, China