Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

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.

Inclusion Criteria:

• 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
• Confirmed orthostatic hypotension
• Stable medical, physical and psychological condition as considered by the investigators
• Able to understand and interact with the study team in French or English
• Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Exclusion Criteria:

• 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
• Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
• Clinically significant mental illness in the judgement of the investigators
• Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment
• Presence of significant pressure ulcers
• Recurrent urinary tract infection refractory to antibiotics
• Presence of indwelling baclofen or insulin pump
• Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,
• Lack of safe contraception for women of childbearing capacity,
• Intention to become pregnant during the course of the study,
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Enrolment of the investigator, his/her family members, employees, and other dependent persons.