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Recruiting NCT06920134

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

No phase Interventional Hypotension Symptomatic Parkinson's Disease Orthostatic Hypotension, Dysautonomic Multiple System Atrophy (MSA) With Orthostatic Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARC-IM Investigational System.
Who it may be relevant to
Registry conditions: Hypotension Symptomatic, Parkinson's Disease, Orthostatic Hypotension, Dysautonomic, Multiple System Atrophy (MSA) With Orthostatic Hypotension. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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,]
  • 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]
  • Time Up and Go Test (TUG) [Time frame: At the end of, 6 months after and 1 year after configuration of the therapy]
  • 2 Minute Walk Test [Time frame: At the end of, 6 months after and 1 year after configuration of the therapy]
  • Berg Balance Test [Time frame: 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) [Time frame: At 6 months and 1 year after configuration of the therapy]
  • System Usability Scale (SUS) [Time frame: At 6 months and 1 year after configuration of the therapy]
  • Additional user feedback of ARC-IM System [Time frame: At 6 months and 1 year after configuration of the therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • CHUV — Lausanne

Identifiers

NCT: NCT06920134 · PD-HemON · HT94252410901 · CDMRP-PD230100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗