Taking people in SwitzerlandNo phase
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.
Key facts
- Who runs it
- Ecole Polytechnique Fédérale de Lausanne
- Where
- Lausanne, SwitzerlandSee the site
- Trial code
- Registry title
- Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
- Status
- Recruiting
- People taking part
- 5 people, planned
- Started
- 3 Jul 2025
- Expected to end
- 1 May 2031
- Type of study
- Interventional
- Treatments tested
- ARC-IM Investigational System
- Record updated
- 7 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with typical or atypical Parkinson's disease who have symptomatic orthostatic hypotension (blood pressure drop on standing) that makes daily life hard.
- Age
- Over 18 years old, up to 90 years
- Sex
- All sexes can join
- Disease stage
- Typical or atypical Parkinson's disease (including Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy) with orthostatic hypotension confirmed by a test for verticalization, with symptoms that make daily activities particularly challenging
- Earlier treatment
- No major change in Parkinson's treatment (such as DBS or dopamine-pump implantation) planned until the end of the main study phase
Main reasons for not taking part
- Cannot stop antiplatelet or anticoagulation medicines around the surgery
- Heart attack or stroke-type event in the past 6 months
- Major psychiatric or major neurocognitive disorder
- Spinal abnormalities that rule out surgery, or need for frequent MRIs
- Current pregnancy or breastfeeding
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- > 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Switzerland
- CHUVLausanne, SwitzerlandContact: Jocelyne BlochTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- All participantsTreatment being tested
All participants will be provided with the ARC-IM Investigational System (implantable and non-implan
Treatment: ARC-IM Investigational System
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
- Plain-language title
- Epidural stimulation device to support blood pressure in Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06920134, who can take part
- Record updated
- 7 July 2026