Epidural electrical stimulation to manage low blood pressure in 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
This study will try epidural electrical stimulation (ARC-IM) to see if it helps people with typical or atypical Parkinson's disease who have symptomatic orthostatic hypotension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT06920134 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with typical or atypical Parkinson's disease (including MSA, pure autonomic failure, or PSP) who have confirmed symptomatic orthostatic hypotension that interferes with daily activities and who can undergo implantation and follow-up at CHUV are ideal candidates.
Not a fit: Patients at high surgical risk, those who cannot safely stop anticoagulation perioperatively, or those whose symptoms are not caused by autonomic failure are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could reduce episodes of symptomatic low blood pressure on standing and improve daily function and tolerance for upright activities.
How similar studies have performed: Related small studies of spinal or epidural stimulation in autonomic failure and spinal cord injury have shown some improvements in blood pressure, but evidence specifically for Parkinson's-related orthostatic hypotension remains limited and preliminary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lausanne, Canton of Vaud
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.