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

NCT06920134 | Recruiting DMC

• 3 other identifiers: PD-HemONHT94252410901CDMRP-PD230100
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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)

Keywords

orthostatic hypotension; parkinson's disease; autonomic failure; hypotension

Outcome Measures

Primary Outcomes (1)

• Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study.

  Evaluate the safety of ARC-IM Therapy in supporting hemodynamic management in participants with atypical or typical Parkinson's Disease and orthostatic hypotension

  Throughout the study (up to 5 years)

Secondary Outcomes (8)

• 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

Other Outcomes (12)

• Doppler ultrasound to measure cerebral blood perfusion with and without the ARC-IM Therapy

  1 month, 6 months and 12 months post-therapy configuration

• Supine hypertension will be evaluated during orthostatic tilt tests without the ARC-IM Therapy

  1 month, 6 months and 12 months post-therapy configuration

• MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II

  1 month, 6 months and 12 months post-therapy configuration

Study Arms (1)

All participants

EXPERIMENTAL

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

Device: ARC-IM Investigational System

Interventions

ARC-IM Investigational System DEVICE

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

All participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Shy-Drager Syndrome; Multiple system atrophy (MSA) with orthostatic hypotension; Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance

Study Officials

• Jocelyne Bloch, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire Courtine, PhD

CONTACT

+41 21 69 30762; gregoire.courtine@epfl.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 9, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

CH (1)