ClinicalTrials.gov record NCT06920134
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional study tests the ARC-IM investigational system — an implanted epidural spinal stimulation device — in people with typical or atypical Parkinson's disease who have symptomatic orthostatic hypotension. All participants receive implantation of a stimulation lead on the low thoracic spinal cord and an abdominal neurostimulator and are followed for safety and preliminary efficacy. The study collects blood-pressure tests, symptom questionnaires, mobility tests, and device usability feedback over follow-up.
What it is studying. The study is testing the safety and preliminary efficacy of the ARC-IM investigational system (epidural electrical stimulation) to support blood-pressure management in people with typical or atypical Parkinson's disease who have symptomatic orthostatic hypotension.
What the researchers hope to learn. The study's scientific goals are to evaluate occurrence of (serious) adverse device effects and to collect preliminary data on whether the ARC-IM therapy affects orthostatic blood-pressure drops, symptom severity (Orthostatic Hypotension Questionnaire), mobility (Time Up and Go, 2-minute walk, Berg Balance), and device usability and satisfaction.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- ARC-IM Investigational System
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Undergo an implantation surgery to place a stimulation lead on the low thoracic spinal cord and a neurostimulator in the abdominal region (an invasive procedure). Have device configuration and in-clinic testing such as a 10-minute head-up tilt test with and without the therapy (including at about 1 month) and follow-up visits at configuration end, 6 months, and 1 year. Complete physical function tests (Time Up and Go, 2-minute walk, Berg Balance) and symptom and device-usability questionnaires (Orthostatic Hypotension Questionnaire, QUEST 2.0, System Usability Scale); safety monitoring for adverse device effects is planned throughout the study (up to 5 years).
How the study is structured. Interventional, single-group (all participants receive the device), non-masked study. Participants undergo implantation of a spinal stimulation lead at the low thoracic level and a neurostimulator in the abdominal region, then attend follow-up visits for safety monitoring and outcome tests. Safety is tracked throughout the study (up to 5 years) and efficacy measures are taken at planned time points after therapy configuration.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Jul 3, 2025
- Primary completion
- May 1, 2031 (estimated)
- Study completion
- May 1, 2031 (estimated)
- Target enrollment
- 5 participants (estimated)
- Last updated on registry
- Jul 7, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Principal investigator
- Jocelyne Bloch, Professor
Centre Hospitalier Universitaire Vaudois
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Gregoire Courtine, PhD 📞 +41 21 69 30762 ✉ gregoire.courtine@epfl.ch
Participating sites (1)
- CHUVRecruiting
Lausanne, Canton of Vaud, 1011 · Switzerland
- Jocelyne Bloch · +41 79 556 2951 · jocelyne.bloch@chuv.ch
Terms used on this page · explanations by MedicalUpdates.ai
- Informed Consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- endpoint
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- Enrolment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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