Epidural electrical stimulation to manage low blood pressure in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PD-HemON protocol implants the ARC-IM epidural electrical stimulation system near the spinal cord to support blood pressure control during upright posture in people with typical or atypical Parkinson's disease. Participants will undergo baseline and post-implant verticalization tests to measure changes in orthostatic blood pressure and related symptoms, with close monitoring for perioperative and device-related safety. The trial is single-center at CHUV in Lausanne and enrolls adults with confirmed symptomatic orthostatic hypotension who can consent in French or English. Study staff will manage medication adjustments and provide device programming with scheduled follow-up visits to collect efficacy and safety outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Chuv
  Lausanne, Canton of Vaud, Switzerland Recruiting

Study contacts

• Principal investigator: Jocelyne Bloch, MD — Chuv
• Study coordinator: Gregoire Courtine, PhD
• Email: gregoire.courtine@epfl.ch
• Phone: +41 21 69 30762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.