The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or similar studies conducted abroad. They will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system. The goal is to improve more effective lower-limb motor activities, while also simplifying the personal at-home use of the system. In addition, this study aims to evaluate the potential effect of ARC Therapy on muscle tone, bladder, bowel and sexual functions, and quality of life of the participants.
Preliminary safety and efficacy will be assessed in both the short term and throughout the duration of the study (from the surgery to 36 months after the implantation of the ARC-IM Lumbar system).
Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
Age 18-65
SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D
SCI ≥ 12months
Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
History of myocardial infarction or cerebrovascular event within the past 6 months
Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
Any active implanted cardiac device such as pacemaker or defibrillator
Single group
Procedure/Surgery
DeviceThe intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.
Preliminary safety of the ARC Therapy
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.
10 Meters Walk test (m/s)
The 10 Meters Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
6 Minutes Walk test (meters)
The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
A neurological assessment and classification of a spinal cord injury
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)
The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
