Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's… (NCT06920134) | Clinical Trial Compass
RecruitingNot Applicable
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Switzerland5 participantsStarted 2025-07-03
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \> 18 years old
✓. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)
✓. Confirmed orthostatic hypotension with a test for verticalization
✓. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians
✓. Must provide and sign the Informed Consent before any study-related procedures
✓. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;
✓. Able to understand and interact with the study team in French or English
✓. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
Exclusion criteria
✕. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
✕. The inability to withhold antiplatelet/anticoagulation agents perioperatively
✕. History of myocardial infarction or cerebrovascular events within the past 6 months
✕. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator
What they're measuring
1
Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study.
✕. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist
✕. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
✕. Inability to follow study procedures.
✕. Spinal anatomical abnormalities precluding surgery