Study on the preliminary safety and efficacy of ARC Therapy using the ARC-IM Lumbar System to support the mobility of individuals with a chronic spinal cord injury (BoxSwitch)

Kriterien zur Teilnahme
- Completion of the main phase of the STIMO study (NCT02936453) and improvement in at least one of the primary or secondary evaluation criteria (WISCI II score, 10-meter walk test (10MWT), weight-bearing capacity test (Weight Bearing Capacity), SCIM III score, or 6-minute walk test (6MWT)) - Age 18-65 years - Spinal cord injury classified according to the AIS scale (American Spinal Injury Association Impairment Scale) A, B, C, and D. - Spinal cord injury older than 12 months - Spinal cord injury above T10, with preservation of conus functions - Spinal cord injury caused by trauma - Stable physical and psychological medical condition as assessed by investigators - Able to understand and interact in French or English with the study team - Agrees to comply in good faith with all study conditions and to attend all scheduled appointments - Must provide and sign informed consent prior to any study-related procedure (BASEC)

Ausschlusskriterien
- Diseases and conditions that would increase morbidity and mortality of spinal cord injury surgery - History of myocardial infarction or stroke within the last 6 months - Limitation of walking function due to accompanying disorders (CNS) (systemic malignant diseases, cardiovascular disorders limiting physical training, peripheral nerve disorders) - Any active implanted cardiac device, such as a pacemaker or defibrillator - Any indication requiring diathermy - Any indication requiring MRI - Any anatomical limitation in the implantation area at the discretion of the investigators - Other conditions that would render the subject unable to participate in the tests at the discretion of the investigators - Clinically significant mental illness at the discretion of the investigators - Presence of an intrathecal baclofen pump or insulin pump - Other clinically significant concomitant pathological states (e.g., renal failure, liver dysfunction, cardiovascular disease, etc.) - Inability to follow study procedures, e.g., due to language issues, psychological disorders, or participant dementia - Inclusion of the investigator, family members, employees, and other dependents - Pregnant women (pregnancy test mandatory for women of childbearing age) or breastfeeding women (BASEC)