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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: ARC-IM Investigational System implantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all participants<br>All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts) | Device: ARC-IM Investigational System implantation<br>* Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Throughout study, an average of 26 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation | 
| Trunk stability measurement (trunk control assessment) | The participant is asked to perform a systematic set of reaching movements, balance and posture tasks while seated freely (without a back-rest). Each task is repeated and pressure, force, kinetic and kinematic data is recorded together with video acquisitions. | Baseline ; at 1 - 13 months after the implantation | 
| 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. | Baseline ; at 1 - 13 months after the implantation | 
| 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 | Baseline ; at 1 - 6.5 - 13 months after the implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury