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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Parkinsonism

Treatments: Device: Transcutaneous spinal cord stimulation; Device: Epidural spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07322458

PDS_OH_tSCS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Epidural spinal cord stimulation (eSCS) implantation

Experimental group

Description:

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.

Treatment:

Device: Epidural spinal cord stimulation

Transcutaneous spinal cord stimulation (tSCS) application

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous spinal cord stimulation