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

N/ARecruitingNCT06920134

Ecole Polytechnique Fédérale de Lausanne5 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypotension Symptomatic Parkinson's Disease Orthostatic Hypotension, Dysautonomic Multiple System Atrophy (MSA) With Orthostatic Hypotension Multiple System Atrophy - Parkinsonian Subtype (MSA-P)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Throughout the study (up to 5 years)

Secondary Outcomes

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)

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.

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 frame: 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)

Time frame: 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)

Time frame: 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.

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)

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.

Time frame: 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.

Time frame: 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

Time frame: At 6 months and 1 year after configuration of the therapy

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts