Hypotension SymptomaticPD-HemONNCT06920134
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease
A study testing ARC-IM Investigational System in people with Hypotension Symptomatic and Parkinson's Disease, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypotension Symptomatic, Parkinson's Disease, Orthostatic Hypotension, Dysautonomic
- What is being tested?
- ARC-IM Investigational System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jul 2025to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Jocelyne Bloch, +41 79 556 2951, jocelyne.bloch@chuv.ch
About this study
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
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.
- Conditions
- Hypotension Symptomatic, Parkinson's Disease, Orthostatic Hypotension, Dysautonomic, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
- Being tested
- ARC-IM Investigational System
- Keywords
- orthostatic hypotension, parkinson's disease, autonomic failure, hypotension
- Medical subject headings
- Parkinson Disease, Shy-Drager Syndrome, Multiple system atrophy (MSA) with orthostatic hypotension, Hypotension, Orthostatic, Pure Autonomic Failure, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-IM Investigational SystemDevice
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will be provided with the ARC-IM Investigational System (implantable and non-implan Receives: Device: ARC-IM Investigational System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the study (up to 5 years)
Secondary outcomes (8)
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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 6 months and 1 year after configuration of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Jul 2025
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension SymptomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jocelyne Bloch, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920134
- Sponsor's protocol ID
- PD-HemON
- Other IDs
- HT94252410901, CDMRP-PD230100
- Acronym
- PD-HemON
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06920134
- Acronym / sponsor ID
- PD-HemON / PD-HemON
- 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's disease, autonomic failure, hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: ARC-IM Investigational SystemAll participants will be provided with the ARC-IM Investigational System (implantable and non-implan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-IM Investigational SystemImplantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region. | Device | All participants |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Related trials for Hypotension Symptomatic
RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
Active, not recruitingPhase 3
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy
RecruitingPhase 3
Early Initiated Vasopressor Therapy in the Emergency Department
Shock, Shock, Septic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jocelyne Bloch, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC-IM Investigational System in people with Hypotension Symptomatic and Parkinson's Disease, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregoire Courtine, PhD (+41 21 69 30762, gregoire.courtine@epfl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.