Actively Recruiting
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-11-18
5
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Diagnosis of typical or atypical Parkinson's Disease, including Multiple System Atrophy, Pure Autonomic Failure, or Progressive Supranuclear Palsy
- Confirmed orthostatic hypotension by a verticalization test
- Symptomatic orthostatic hypotension that significantly affects daily activities as determined by study clinicians
- Signed informed consent before any study procedures
- Stable medical, physical, and psychological conditions as judged by investigators
- Ability to understand and communicate with the study team in French or English
- Willingness to comply with study conditions and attend all scheduled visits
You will not qualify if you...
- Conditions that increase risks of implantation surgery
- Unable to stop antiplatelet or anticoagulant medications around surgery
- History of heart attack or stroke within 6 months
- Unstable or serious medical conditions that interfere with the study
- Major psychiatric or neurocognitive disorders as determined by investigators
- Planned major changes in Parkinson's treatment during the main study phase
- Unable to follow study procedures
- Spinal abnormalities preventing surgery
- Need for frequent MRI scans
- Current pregnancy or breastfeeding
- Lack of effective contraception for women who can become pregnant
- Plans to become pregnant during the study
- Unable or unwilling to use the study device effectively
- Participation in another interventional study that might affect results
- Investigator or related persons enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
G
Gregoire Courtine, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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