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Recruiting NCT06920134

Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease

Trial Parameters

Condition Hypotension Symptomatic
Sponsor Ecole Polytechnique Fédérale de Lausanne
Study Type INTERVENTIONAL
Phase N/A
Enrollment 5
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2025-07-03
Completion 2031-05-01
Interventions
ARC-IM Investigational System

Brief Summary

The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.

Eligibility Criteria

Inclusion Criteria: 1. \> 18 years old 2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy) 3. Confirmed orthostatic hypotension with a test for verticalization 4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians 5. Must provide and sign the Informed Consent before any study-related procedures 6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators; 7. Able to understand and interact with the study team in French or English 8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery 2. The inability to withhold antiplatelet/anticoagulation agents perioperatively 3. History of myocardial i

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