Epidural stimulation device to support blood pressure in Parkinson's disease
Tests an implanted stimulation device in adults with Parkinson's and standing low blood pressure.
Plain-language title generated from the registry record
Registry title: Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Key facts
- Where
- Lausanne, SwitzerlandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06920134, who can take part
Where in Switzerland
- CHUVLausanne, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ecole Polytechnique Fédérale de Lausanne
- Trial code
- NCT06920134
- Record updated
- 7 July 2026
- Original description
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.Read full original descriptionShow less
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
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.
Inclusion: > 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: Spinal anatomical abnormalities precluding surgery; Diseases and conditions that would increase the morbidity and mortality of the implantation surgery; 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; 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; The inability to withhold antiplatelet/anticoagulation agents perioperatively; 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; Presence of any indications requiring frequent MRIs; Current pregnancy or current breastfeeding; Lack of effective or acceptable contraception for women of childbearing capacity; Intention to become pregnant during the study; Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator; Participation in another interventional study that might confound study endpoint evaluations; Enrolment of the investigator, his/her family members, employees, and other dependent persons.