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)
Résumé de l'étude
This study aims to evaluate the preliminary safety and efficacy of ARC Therapy, which uses an implantable spinal cord electrical stimulation system, with the goal of promoting mobility and potentially improving other clinical functions such as spasticity following a chronic spinal cord injury. The study will assess the safety of using the system and associated procedures to properly integrate it into standard clinical rehabilitation programs. It will also evaluate the safety and efficacy of the therapy in the short and long term on mobility, spasticity, bowel, urinary, and sexual functions, as well as quality of life.
(BASEC)
Intervention étudiée
In this study, participants who have completed the STIMO study protocol (SNCTP000001953) will be offered to replace their currently implanted Activa RC stimulator with the ARC-IM IPG to demonstrate that the expanded set of stimulation capabilities can be integrated into the personalization of the SCS protocols. The aim is to improve the efficiency of lower limb motor activities while simplifying the personal use of the system at home. Additionally, under certain conditions (current status of implanted devices, technical and surgical compatibility) and evaluated on a case-by-case basis, this study provides for a strategy to replace the stimulation lead.
(BASEC)
Maladie en cours d'investigation
Spinal cord injury
(BASEC)
- 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)
Critères d'exclusion
- 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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
-
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Grégoire Courtine
+41 21 69 30762
gregoire.courtine@clutterepfl.chEPFL
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
24.08.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Study on preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System to support mobility in people with chronic spinal cord injury (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible