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

Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease

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 Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Multiple System Atrophy - Parkinsonian Subtype (MSA-P); Multiple System Atrophy (MSA) With Orthostatic Hypotension; Orthostatic Hypotension, Dysautonomic; Hypotension Symptomatic
• Intervention / Treatment: Device: ARC-IM Investigational System

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregoire Courtine, PhD; Phone Number: +41 21 69 30762; Email: gregoire.courtine@epfl.ch

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Recruiting
      • CHUV
      • Contact: Jocelyne Bloch; Phone Number: +41 79 556 2951; Email: jocelyne.bloch@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; All participants will be provided with the ARC-IM Investigational System (implantable and non-implan	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention	Preliminary and long-term efficacy of the ARC-IM Therapy to reduce orthostatic hypotension. Measurement tool: Drop in blood pressure over time (mmHg and sec, mmHg/sec)	At the end of, 6 months after and 1 year after configuration of the therapy,
Severity of symptoms measured by The Orthostatic Hypotension Questionnaire.	This outcome measures the preliminary long-term efficacy of the ARC-IM Therapy to support hemodynamic instability. The Orthostatic Hypotension Questionnaire (OHQ) has 10 hypotension symptom-related items rated on a 11 point scale (0 - 10). Measurement tool: 0 indicates no symptoms and 10 indicates worst possible severity/outcome. A higher total score indicates worse symptomatology.	At the end of, 6 months after and 1 year after configuration of the therapy
Time Up and Go Test (TUG)	Preliminary efficacy of the ARC-IM Therapy to improve physical activity. The Time Up and Go will measure time from sit to stand and gait quality. Measurement tool: time (sec)	At the end of, 6 months after and 1 year after configuration of the therapy
2 Minute Walk Test	Preliminary efficacy of the ARC-IM Therapy to improve physical activity. The 2 Minute Walk Test (2MWT) will measure gait endurance and distance walked over 2 minutes. Measurement tool: distance (meters)	At the end of, 6 months after and 1 year after configuration of the therapy
Berg Balance Test	The Berg Balance Test measures the ability to balance safely with 14 specific tasks performed while standing, sitting, or making simple movements. The test scoring ranges from 0 to 56. Measurement tool: lower score indicates greater risk of losing your balance.	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)	To measure the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The Quebec User Evaluation of Satisfaction with technology (QUEST 2.0) is a 12-item instrument that evaluates satisfaction with the therapy across form factor, safety, durability, simplicity of use, comfort, service of device and improvements. The evaluation will be performed by a moderator with the participant. Measurement tool: Total score from 12 to 60. Low score means a better outcome.	At 6 months and 1 year after configuration of the therapy
System Usability Scale (SUS)	Assess the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The System Usability Scale (SUS) is a 10-item scale that evaluates the usability and satisfaction of the technology. Measurement tool: Total score from 0 to 100. Higher score indicates better outcome.	At 6 months and 1 year after configuration of the therapy
Additional user feedback of ARC-IM System	To assess the usability of the ARC-IM Main Controller, Clinician Programmer, and Personal Programmer for clinicians and participants. The Additional user feedback of ARC-IM System is a custom-made user feedback questionnaire to evaluate the overall satisfaction of specific aspects of the therapy including battery life, device communication etc. Measurement tool: Total score where applicable (higher score indicates better outcome) and feedback from participants	At 6 months and 1 year after configuration of the therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measurement tool: blood pressure (mmHg) during supine position of orthostatic tilt test	1 month, 6 months and 12 months post-therapy configuration
MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II	Participants' quality of life will be assessed with MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II to measure sleep, mental health, and fatigue (MDS-UPDRS-IB & II) over 20 items. Measurement tool: Total score (0 - 4 rating per question), 0 represents no impairment and 4 represents severe impairment. Higher total score indicates worse symptoms.	1 month, 6 months and 12 months post-therapy configuration
King's Parkinson's Disease Pain Scale	Participants' quality of life will be assessed with the 7-item King's Parkinson's Disease Pain Scale to characterize severity and types of pain associated with Parkinson's Disease. Measurement tool: Total score from 0 to 168. Lower score indicates a better outcome.	1 month, 6 months and 12 months post-therapy configuration
Parkinson's Disease Questionnaire-39 (PDQ-39)	Participants' quality of life will be measured by the 39 item Parkinson's Disease Questionnaire-39 (PDQ-39) to evaluate perceived health in terms of physical, mental and social functions. Measurement tool: Total score from 0-100, higher scores reflect lower quality of life	1 month, 6 months and 12 months post-therapy configuration
Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction	Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT) is a 25-item, self-completed questionnaire to evaluate autonomic symptoms in people with typical and atypical Parkinson's Disease. Measurement tool: Total score from 0-69 where a higher score indicates increased frequency of autonomic dysfunction symptoms	1 month, 6 months and 12 months post-therapy configuration
MDS sponsored Unified Parkinson's Disease Rating Scale Part III	Participants' quality of life will be assessed with the MDS-sponsored Unified Parkinson's Disease Rating Scale Part III (19 items) to evaluate motor function. Measurement tool: Total score from 0 to 132. Low score means a better outcome.	Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration
24 hour ambulatory measurements	Participant's quality of life will be evaluated with 24 hour blood pressure measurements with and without the therapy. Measurement tool: blood pressure (mmHg)	Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration
Closed-loop stimulation on management of hemodynamics will be measured with the change in blood pressure during 10 minute, head up tilt tests.	Closed-loop stimulation will receive feedback from a blood pressure sensor to automatically adjust stimulation intensity. We will evaluate the effects of this stimulation on management of hemodynamics during configuration sessions with pre-configured stimulations, with closed-loop stimulation and without stimulation. The feasibility and effectiveness will be measured by the drop in blood pressure (mmHg) during 10 minute, orthostatic, head-up tilt tests.	Post-operative configuration phases, through year 1 of the study
Time Up and Go Test across different therapeutic conditions	The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the Time Up and Go will measure time from sit to stand and gait quality. Measurement tool: time (sec)	Post-operative configuration phases, through year 1 of the study
2 Minute Walk Test across different therapeutic conditions	The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the The 2 Minute Walk Test (2MWT) will measure gait endurance and distance walked over 2 minutes. Measurement tool: distance (meters)	Post-operative configuration phases, through year 1 of the study
Berg Balance Test across different therapeutic conditions	The complementarity of the ARC-IM Therapy with standard therapies (e.g LDopa) will be assessed over the trajectory of therapy intake with and without stimulation during configuration phases with the Berg Balance Test measures the ability to balance safely with 14 specific tasks performed while standing, sitting, or making simple movements. Measurement tool: Total score from 0-56, lower score indicates greater risk of losing your balance.	Post-operative configuration phases, through year 1 of the study

Collaborators and Investigators

• Sponsor: Ecole Polytechnique Fédérale de Lausanne
• Investigators: Principal Investigator: Jocelyne Bloch, MD, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: orthostatic hypotension; autonomic failure; hypotension; parkinson's disease
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Multiple System Atrophy; Hypotension; Parkinson Disease; Shy-Drager Syndrome; Hypotension, Orthostatic; Pure Autonomic Failure; Multiple system atrophy (MSA) with orthostatic hypotension
• Other Study ID Numbers: PD-HemON; HT94252410901 (Other Grant/Funding Number: Department of Defense, USAMRAA); CDMRP-PD230100 (Other Grant/Funding Number: CDMRP-Proposal Log Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No