Hypotension Symptomatic, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Multiple System Atrophy - Parkinsonian Subtype (MSA-P), Orthostatic Hypotension, Dysautonomic, Parkinson's Disease
Conditions
Keywords
orthostatic hypotension, parkinson's disease, autonomic failure, hypotension
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.
Interventions
DEVICEARC-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.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study. | 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
| Measure | Time frame | Description |
|---|---|---|
| 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention | 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) |
| Severity of symptoms measured by The Orthostatic Hypotension Questionnaire. | 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. |
| Time Up and Go Test (TUG) | 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) |
| 2 Minute Walk Test | 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) |
| Berg Balance Test | 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. |
| Quebec User Evaluation of Satisfaction with technology (QUEST 2.0) | 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. |
| System Usability Scale (SUS) | 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. |
| Additional user feedback of ARC-IM System | 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 |
Countries
Switzerland
Contacts
CONTACTGregoire Courtine, PhD
PRINCIPAL_INVESTIGATORJocelyne Bloch, MD
CHUV
Outcome results
None listed