Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Device: ARC-IM Investigational System implantation
- Registration Number
- NCT05111093
- Lead Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description all participants ARC-IM Investigational System implantation All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
CHUV
🇨🇭Lausanne, Vaud, Switzerland