NCT06920134RecruitingNot Applicable
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
Ecole Polytechnique Fédérale de Lausanne2 sites in 1 country5 target enrollmentStarted: July 3, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 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
Exclusion Criteria
- •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
Arms & Interventions
All participants
Experimental
All participants will be provided with the ARC-IM Investigational System (implantable and non-implan
Intervention: ARC-IM Investigational System (Device)
Outcomes
Primary Outcomes
Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study.
Time Frame: Throughout the study (up to 5 years)
Evaluate the safety of ARC-IM Therapy in supporting hemodynamic management in participants with atypical or typical Parkinson's Disease and orthostatic hypotension
Secondary Outcomes
- 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention(At the end of, 6 months after and 1 year after configuration of the therapy,)
- Severity of symptoms measured by The Orthostatic Hypotension Questionnaire.(At the end of, 6 months after and 1 year after configuration of the therapy)
- Time Up and Go Test (TUG)(At the end of, 6 months after and 1 year after configuration of the therapy)
- 2 Minute Walk Test(At the end of, 6 months after and 1 year after configuration of the therapy)
- Berg Balance Test(At the end of, 6 months after and 1 year after configuration of the therapy)
- Quebec User Evaluation of Satisfaction with technology (QUEST 2.0)(At 6 months and 1 year after configuration of the therapy)
- System Usability Scale (SUS)(At 6 months and 1 year after configuration of the therapy)
- Additional user feedback of ARC-IM System(At 6 months and 1 year after configuration of the therapy)
Investigators
Jocelyne Bloch
Professor
Centre Hospitalier Universitaire Vaudois
Study Sites (2)
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