NCT06920134Recruiting
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 3 Jul 2025
- Primary completion date
- 1 May 2031
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Diseases
- Parkinson disease
- NCT number
- NCT06920134
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 3 Jul 2025 to the primary completion date, 1 May 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Spinal anatomical abnormalities precluding surgery
Other illness
- 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
Other
- 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
Who the study is looking for
- \> 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.