Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease

Recruiting now · Not applicable

Conditions studied: Hypotension Symptomatic, Parkinson's Disease, Orthostatic Hypotension, Dysautonomic, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Multiple System Atrophy - Parkinsonian Subtype (MSA-P)

In brief

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.

Key facts

Study ID

NCT06920134

Run by

Ecole Polytechnique Fédérale de Lausanne

People needed

5

Starts

2025-07-03

Expected to finish

2031-05-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
• The inability to withhold antiplatelet/anticoagulation agents perioperatively
• 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
• 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.
• Spinal anatomical abnormalities precluding surgery
• 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

Where it is running

• CHUV — Lausanne, Canton of Vaud, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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