The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.
18 years of age or older
Must provide and sign the Informed Consent prior to any study related procedures
Spinal cord injury lesion level between C3 and T6 (inclusive)
SCI ≥ 1month
SCI related to a neurodegenerative disease
Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
The inability to withhold antiplatelet/anticoagulation agents perioperatively
History of myocardial infarction or cerebrovascular event within the past 6 months
Single group
ARC-IM Investigational System implantation
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 Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System
Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension
Orthostatic head-up tilt test (hemodynamic stability assessment)
Participant begin by resting in the supine position during which baseline measures are performed. Thereafter, participant is passively moved to upright position using a tilt-table and kept in this position for a maximum of 10 minutes. This test will be performed with and without ARC-IM Therapy. Beat by beat blood pressure is monitored and catecholamine concentrations in the plasma are measured during the tilt-test.
Modified Ashworth Scale (MAS) (spasticity assessment)
Participants' upper and lower limb spasticity levels (6 points nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. This test will be performed with and without ARC-IM Therapy. Scores range from 0 to 5 (0, 1, 1+, 2, 3, 4, 5) with higher scores indicating higher spasticity.
SCIM III (daily life performance assessment)
The Spinal Cord Independence Measure (SCIM) is a disability score to assess functional activity in participants. Function is assessed in 3 areas of function: self-care (0-20), respiration and sphincter management (0-40) and mobility (0-40). Total score ranges between 0-100, with higher scores reflecting greater functional ability
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
