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NCT07879391

Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension

Sponsor: Aerospace Center Hospital

View on ClinicalTrials.gov

Summary

Neurogenic orthostatic hypotension is a disabling manifestation of synucleinopathies including Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and pure autonomic failure. It commonly coexists with supine hypertension and requires individualized management. An implanted thoracic epidural stimulation system improved blood-pressure regulation, standing, and walking in a patient with multiple system atrophy, providing a rationale for further feasibility evaluation. This study evaluates the feasibility, safety, and preliminary hemodynamic response of lower thoracic epidural spinal cord stimulation in participants with symptomatic neurogenic orthostatic hypotension. All participants undergo surgical percutaneous placement of a lower thoracic epidural spinal cord stimulation lead, followed by an externalized trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is evaluated with a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants who meet predefined response and safety criteria receive permanent implantation of the compatible spinal cord stimulation system. After permanent implantation, follow-up occurs at 1, 3, 6, and 12 months to evaluate symptom improvement and safety.

Official title: A Prospective, Single-Center, Open-Label, Single-Arm Feasibility Study of Lower Thoracic Epidural Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-01

Completion Date

2029-12-31

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Neurogenic Orthostatic Hypotension

Interventions

DEVICE

Lower thoracic epidural spinal cord stimulation

A 16-contact epidural spinal cord stimulation lead is placed with active contacts covering the intended T10 to T12 region. The lead is externalized for a trial stimulation period generally lasting no more than 2 weeks. During this period, the acute hemodynamic effect of stimulation is assessed using a within-participant randomized stimulation ON/OFF comparison during a standardized orthostatic challenge. Participants meeting predefined response and safety criteria proceed to permanent implantation of the compatible spinal cord stimulation system. Initial programming uses individualized low-to-high titration within the device instructions for use: frequency 5 to 50 Hz and pulse width 200 to 500 μs. Amplitude increases from a subperception or lowest perceptible level until hemodynamic benefit, intolerable symptoms, or the device-specific permitted limit is reached.

Inclusion Criteria: * Age 18 to 80 years. * Diagnosis of Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, or pure autonomic failure by a neurologist using applicable accepted diagnostic criteria at screening. * Neurogenic orthostatic hypotension documented by a standardized active standing test or tilt-table test: after at least 5 minutes of supine rest, a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing. A systolic reduction of at least 30 mmHg may support eligibility in participants with supine hypertension. * Orthostatic symptoms or fall risk that remain clinically meaningful despite standardized nonpharmacologic management and stable usual medical management. * Ability to understand study procedures and provide written informed consent. Participants with mild cognitive impairment require sufficient ability to complete safety assessments and, where required by the ethics committee, involvement of a legally authorized representative. Exclusion Criteria: * Orthostatic hypotension primarily attributable to a non-neurogenic or reversible cause, including uncorrected hypovolemia, recent major blood loss, or an active medication-adjustment period. * Uncontrolled heart failure, active myocardial ischemia, clinically significant arrhythmia, or other cardiovascular disease making surgery, sedation, or orthostatic testing unsafe. * Persistent severe supine hypertension, defined as repeated systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 110 mmHg after clinical optimization, that makes stimulation titration unsuitable. * Active infection, coagulopathy, inability to interrupt anticoagulant or antiplatelet therapy when required for epidural procedures, or another contraindication to epidural access or implantation. * Severe thoracolumbar spinal deformity, prior fusion in the intended lead-placement region, or imaging evidence that makes epidural placement unsuitable. * An implanted electronic medical device that is contraindicated or cannot be safely managed with the study stimulation system after specialist assessment. * Severe cognitive, psychiatric, or communication impairment that prevents safe participation, symptom reporting, or follow-up. * Pregnancy, breastfeeding, or planned pregnancy during study follow-up.