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.
> 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
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
Single group
ARC-IM Investigational System
DeviceImplantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
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
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)
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 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)
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)
Doppler ultrasound to measure cerebral blood perfusion with and without the ARC-IM Therapy
Supine hypertension will be evaluated during orthostatic tilt tests without the ARC-IM Therapy
Measurement tool: blood pressure (mmHg) during supine position of orthostatic tilt test
MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB & II
Participants' quality of life will be assessed with MDS-sponsored Unified Parkinson's Disease Rating Scale Part IB \& II to measure sleep, mental health, and fatigue (MDS-UPDRS-IB \& II) over 20 items. Measurement tool: Total score (0 - 4 rating per question), 0 represents no impairment and 4 represents severe impairment. Higher total score indicates worse symptoms.
King's Parkinson's Disease Pain Scale
Participants' quality of life will be assessed with the 7-item King's Parkinson's Disease Pain Scale to characterize severity and types of pain associated with Parkinson's Disease. Measurement tool: Total score from 0 to 168. Lower score indicates a better outcome.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
