Overview
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
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.