About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ARC-IM Investigational System implantation
Treatment groups
Sponsors and collaborators
Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution