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

NCT07322458 | Not Yet Recruiting

• 1 other identifier: PDS_OH_tSCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsonism

Outcome Measures

Primary Outcomes (7)

• Change of blood pressure from baseline to immediately post-operation 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.

  Immediately post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 3 months post-operation 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.

  3 months post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 6 months post-operation 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.

  6 months post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 9 months post-operation 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.

  9 months post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 12 months post-operation 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.

  12 months post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 18 months post-operation 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.

  18 months post surgery or post transcutaneous stimulation

• Change of blood pressure from baseline to 24 months post-operation 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.

  24 months post surgery or post transcutaneous stimulation

Secondary Outcomes (140)

• 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

Study Arms (2)

Epidural spinal cord stimulation (eSCS) implantation

EXPERIMENTAL

Phase I: (1) Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively and by the patient's feedback of the current stimulation position until the current can cover the entire area. (2) An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience. Phase II: The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.

Device: Epidural spinal cord stimulation

Transcutaneous spinal cord stimulation (tSCS) application

EXPERIMENTAL

After completing the necessary assessments and informed consent procedures, subjects will undergo device installation and seated programming. The cathode of the tSCS device will be placed at the level of the lower thoracic spinal cord via a hydrogel adhesive electrode, and the anode will be placed bilaterally at the iliac crest via a hydrogel adhesive electrode. During seated programming, subjects will undergo continuous non-invasive blood pressure monitoring and a medication-free head-up tilt test (TTT). If subjects demonstrate a satisfactory clinical response during the testing phase (defined as an increase in systolic blood pressure of more than 15-20 mmHg with stimulation on compared to the off state), they will enter regular tSCS therapy during the treatment phase.

Device: Transcutaneous spinal cord stimulation

Interventions

Epidural spinal cord stimulation DEVICE

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.

Epidural spinal cord stimulation (eSCS) implantation

Transcutaneous spinal cord stimulation DEVICE

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.

Transcutaneous spinal cord stimulation (tSCS) application

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged between 40 and 80 years;
• \. 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);
• \. Able and willing to follow instruction of the researcher;

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (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

Location

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Central Study Contacts

Jun LIU, MD, PhD

CONTACT

021-64370045; jly0520@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)