Clinical trial NCT06920134: Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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&#39;s disease
autonomic failure
hypotension
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study.
timeFrame: Throughout the study (up to 5 years)
Secondary outcomes:
measure: 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention
timeFrame: At the end of, 6 months after and 1 year after configuration of the therapy,
measure: Severity of symptoms measured by The Orthostatic Hypotension Questionnaire.
timeFrame: At the end of, 6 months after and 1 year after configuration of the therapy
measure: Time Up and Go Test (TUG)
timeFrame: At the end of, 6 months after and 1 year after configuration of the therapy
measure: 2 Minute Walk Test
timeFrame: At the end of, 6 months after and 1 year after configuration of the therapy
measure: Berg Balance Test
timeFrame: At the end of, 6 months after and 1 year after configuration of the therapy
measure: Quebec User Evaluation of Satisfaction with technology (QUEST 2.0)
timeFrame: At 6 months and 1 year after configuration of the therapy
measure: System Usability Scale (SUS)
timeFrame: At 6 months and 1 year after configuration of the therapy
measure: Additional user feedback of ARC-IM System
timeFrame: At 6 months and 1 year after configuration of the therapy
Other outcomes:
measure: Doppler ultrasound to measure cerebral blood perfusion with and without the ARC-IM Therapy
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: Supine hypertension will be evaluated during orthostatic tilt tests without the ARC-IM Therapy
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: King's Parkinson's Disease Pain Scale
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction
timeFrame: 1 month, 6 months and 12 months post-therapy configuration
measure: MDS sponsored Unified Parkinson's Disease Rating Scale Part III
timeFrame: Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration
measure: 24 hour ambulatory measurements
timeFrame: Baseline (before surgery), and 1 month, 6 months and 12 months post-therapy configuration
measure: Closed-loop stimulation on management of hemodynamics will be measured with the change in blood pressure during 10 minute, head up tilt tests.
timeFrame: Post-operative configuration phases, through year 1 of the study
measure: Time Up and Go Test across different therapeutic conditions
timeFrame: Post-operative configuration phases, through year 1 of the study
measure: 2 Minute Walk Test across different therapeutic conditions
timeFrame: Post-operative configuration phases, through year 1 of the study
measure: Berg Balance Test across different therapeutic conditions
timeFrame: Post-operative configuration phases, through year 1 of the study
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Valud
Study officials:
affiliation: CHUV
name: Jocelyne Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References: