Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• \> 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

Locations
Other Locations
Switzerland
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Gregoire Courtine, PhD
gregoire.courtine@epfl.ch
+41 21 69 30762
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2031-05-01
Participants
Target number of participants: 5
Treatments
Experimental: All participants
All participants will be provided with the ARC-IM Investigational System (implantable and non-implan
Sponsors
Leads: Ecole Polytechnique Fédérale de Lausanne

This content was sourced from clinicaltrials.gov