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Clinical Trial

Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension

NCT: NCT07879391 · NOT_YET_RECRUITING

NCT IDNCT07879391
StatusNOT_YET_RECRUITING
Start Date2026-12-01
Completion2029-12-31
SponsorAerospace Center Hospital (OTHER)
First posted
Last updated

Brief 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 Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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