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NCT Number: NCT06920134

Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With 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.

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Key information

Conditions

Hypotension Symptomatic Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Movement Disorders Multiple System Atrophy Multiple System Atrophy (MSA) With Orthostatic Hypotension Multiple System Atrophy - Parkinsonian Subtype (MSA-P) Nervous System Diseases Neurodegenerative Diseases Orthostatic Hypotension, Dysautonomic Orthostatic Intolerance Parkinson Disease Parkinson's Disease Parkinsonian Disorders Primary Dysautonomias Pure Autonomic Failure Shy-Drager Syndrome Synucleinopathies Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention

    Time frame: At the end of, 6 months after and 1 year after configuration of the therapy,

    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)

  2. Severity of symptoms measured by The Orthostatic Hypotension Questionnaire.

    Time frame: At the end of, 6 months after and 1 year after configuration of the therapy

    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.

  3. Time Up and Go Test (TUG)

    Time frame: At the end of, 6 months after and 1 year after configuration of the therapy

    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)

  4. 2 Minute Walk Test

    Time frame: At the end of, 6 months after and 1 year after configuration of the therapy

    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)

  5. Berg Balance Test

    Time frame: At the end of, 6 months after and 1 year after configuration of the therapy

    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.

  6. Quebec User Evaluation of Satisfaction with technology (QUEST 2.0)

    Time frame: At 6 months and 1 year after configuration of the therapy

    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.

  7. System Usability Scale (SUS)

    Time frame: At 6 months and 1 year after configuration of the therapy

    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.

  8. Additional user feedback of ARC-IM System

    Time frame: At 6 months and 1 year after configuration of the therapy

    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

Other outcomes

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

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

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

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

    Measurement tool: blood pressure (mmHg) during supine position of orthostatic tilt test

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

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

    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.

  4. King's Parkinson's Disease Pain Scale

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

    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.

  5. Parkinson's Disease Questionnaire-39 (PDQ-39)

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

    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

  6. Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction

    Time frame: 1 month, 6 months and 12 months post-therapy configuration

    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

  7. MDS sponsored Unified Parkinson's Disease Rating Scale Part III

    Time frame: Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration

    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.

  8. 24 hour ambulatory measurements

    Time frame: Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration

    Participant's quality of life will be evaluated with 24 hour blood pressure measurements with and without the therapy.

    Measurement tool: blood pressure (mmHg)

  9. Closed-loop stimulation on management of hemodynamics will be measured with the change in blood pressure during 10 minute, head up tilt tests.

    Time frame: Post-operative configuration phases, through year 1 of the study

    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.

  10. Time Up and Go Test across different therapeutic conditions

    Time frame: Post-operative configuration phases, through year 1 of the study

    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)

  11. 2 Minute Walk Test across different therapeutic conditions

    Time frame: Post-operative configuration phases, through year 1 of the study

    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)

  12. Berg Balance Test across different therapeutic conditions

    Time frame: Post-operative configuration phases, through year 1 of the study

    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.

  13. Montréal Cognitive Assessment (MoCA)

    Time frame: Baseline, 1 month, 6 months and 12 months post-therapy configuration

    To objectively characterize and longitudinally monitor cognitive status over the course of the study, the Montréal Cognitive Assessment (MoCA) will be performed. This assessment evaluates several cognitive domains including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation and orientation.

    Measurement tool: Total score (0-30), with higher scores indicating better cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregoire Courtine, PhD

CONTACT

[email protected]

+41 21 69 30762

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Registry information

Official study title

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

Acronym: PD-HemON

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 9, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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