Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease (PD-HemON)

Ecole Polytechnique Fédérale de Lausanne

Status: Enrolling

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

Treatments: Device: ARC-IM Investigational System

Study type: Interventional

Funder types: Other

Identifiers

NCT06920134

HT94252410901 (Other Grant/Funding Number)

CDMRP-PD230100 (Other Grant/Funding Number)

PD-HemON

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

All participants

Experimental group

Description:

All participants will be provided with the ARC-IM Investigational System (implantable and non-implan

Treatment:

Device: ARC-IM Investigational System