An interventional study of Procedure/Surgery in Spinal Cord Injuries, sponsored by Ecole Polytechnique Fédérale de Lausanne. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Ecole Polytechnique Fédérale de Lausanne · Not applicable, Interventional, and Treatment
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).
Studies have shown that using Electrical Epidural Stimulation (EES) could improve considerably the functional movements after paralyzing SCI. In the STIMO study (NCT02936453), the investigational system was mainly composed of medical devices developed for other indications and used off-label, allowing only a limited tuning of EES protocols. To overcome this limitation, we propose to conduct a study in which a new platform will be investigated. This new therapy, named ARC Therapy, features the ARC-IM implantable pulse generator with an optimized communication system and the ARC-IM implantable leads supporting stimulation protocols specifically developed for effective activation of motor neurons.
The study will take place at the CHUV (Lausanne, Switzerland). A maximum of 8 participants will be enrolled in the study and implanted with an ARC-IM IPG. Patients who previously received an implantation in international studies for continuous electrical stimulation can enroll in the current BoxSwitch study. Replacement of their currently implanted IPG and lead will be assessed on a case-by-case manner considering current status of their implanted devices, technical and surgical compatibility with the newly proposed ARC-IM Lumbar system components.
The study intervention consists of several phases preceded by pre-screening:
Screening and enrollment, baseline and pre-implantation assessments, surgery, optimization phase, short-term assessments, independent use phase and follow-up assessments at months 12, 24 and 36. Measures will be performed before surgical intervention and at regular intervals during the study.
The total duration of the study will be approximately 48 months (up to 36 months/participant).
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 8 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Ecole Polytechnique Fédérale de Lausanne is the lead sponsor of 20 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study: the participants who have previously received a spinal array and an implantable pulse generator either through the STIMO study or similar studies conducted abroad will be proposed to exchange their currently implanted system with selected components from the ARC-IM Lumbar system. After the surgery, the participants will perform around 20 optimization sessions that may include rehabilitation to configure the neuromodulation system. Then the participants will use the ARC-IM Lumbar system independently during daily life activities until the end of the 36 months post-surgery. Assessments will be planned throughout the course of the study at the end of the optimization phase, after 12 and 24 months post-surgery and at the end of the study, with and/or stimulation.
Device: Procedure/Surgery
The 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.
Time frame: Through study completion (expected 3 years)
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.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
6 Minutes Walk test (meters)
The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
International Standards For Neurological Classification of Spinal Injury (ISNCSCI)
A neurological assessment and classification of a spinal cord injury
Time frame: Baseline, 12 months, 24 months and 36 months
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)
The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Neuromuscular Recovery Scale (NRS)
The NRS is used to measure quality of movement without compensatory movement patterns using a body weight support system and a treadmill.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Walking Index for Spinal Cord Injury (WISCI II)
The Walking Index for Spinal Cord Injury (WISCI) is a scale that measures the type and amount of assistance (in terms of requirements of assistive devices, or human helpers) required by a person with spinal cord injury (SCI) for walking.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Modified Ashworth Scale (MAS)
The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone.
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Spinal Cord Independence Measure (SCIM III)
The SCIM address specific areas of function in patients with spinal cord injuries (SCI).
Time frame: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months
Quality of Life questionnaires
Questionnaires addressing bowel, bladder and sexual functions.
Time frame: Monthly during the first year
Plan to share: No
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Ecole Polytechnique Fédérale de Lausanne