NCT06920134 Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
| NCT ID | NCT06920134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne |
| Condition | Hypotension Symptomatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2031-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-07-03 with a primary completion date of 2031-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. \> 18 years old 2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy) 3. Confirmed orthostatic hypotension with a test for verticalization 4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians 5. Must provide and sign the Informed Consent before any study-related procedures 6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators; 7. Able to understand and interact with the study team in French or English 8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery 2. The inability to withhold antiplatelet/anticoagulation agents perioperatively 3. History of myocardial infarction or cerebrovascular events within the past 6 months 4. 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 5. 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 6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation) 7. Inability to follow study procedures. 8. Spinal anatomical abnormalities precluding surgery 9. Presence of any indications requiring frequent MRIs. 10. Current pregnancy or current breastfeeding 11. Lack of effective or acceptable contraception for women of childbearing capacity 12. Intention to become pregnant during the study 13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator 14. Participation in another interventional study that might confound study endpoint evaluations 15. Enrolment of the investigator, his/her family members, employees, and other dependent persons
Contact & Investigator
Jocelyne Bloch, MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT06920134 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Hypotension Symptomatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06920134 currently recruiting?
Yes, NCT06920134 is actively recruiting participants. Contact the research team at gregoire.courtine@epfl.ch for enrollment information.
Where is the NCT06920134 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06920134 clinical trial?
NCT06920134 is sponsored by Ecole Polytechnique Fédérale de Lausanne. The principal investigator is Jocelyne Bloch, MD at CHUV. The trial plans to enroll 5 participants.