Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injury
Brief summary
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.
Interventions
DEVICEARC-IM Investigational System implantation
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Throughout study, an average of 26 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic head-up tilt test (hemodynamic stability assessment) | Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation | 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) | Baseline ; at 1 - 13 months after the implantation | 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) | Baseline ; at 1 - 6.5 - 13 months after the implantation | 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 |
Countries
Switzerland
Contacts
Primary ContactGregoire Courtine, Prof
Outcome results
None listed