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

NCT ID: NCT06920134

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2031-05-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All participants

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

Group Type: EXPERIMENTAL

ARC-IM Investigational System

Intervention Type: DEVICE

Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.

Interventions

ARC-IM Investigational System

Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Jocelyne Bloch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jocelyne Bloch, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Gregoire Courtine, PhD

Role: CONTACT

gregoire.courtine@epfl.ch

+41 21 69 30762

Facility Contacts

Jocelyne Bloch

Role: primary

jocelyne.bloch@chuv.ch

+41 79 556 2951

Other Identifiers

HT94252410901

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDMRP-PD230100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PD-HemON

Identifier Type: -

Identifier Source: org_study_id