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 (BoxSwitch)

Study Overview
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Brief Summary
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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 with chronic spinal cord injury. Only participants that have undergone the STIMO study (NCT02936453) 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).

Detailed Description
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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. Only participants that have undergone the STIMO protocol (NCT02936453) can enrol 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).

Official Title
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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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Procedure/Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having completed the main phase of the STIMO study (NCT02936453) and having improved on at least one of the primary or secondary endpoints (WISCI II Score, 10-Meter Walk test, Weight Bearing Capacity, SCIM III Score or 6-Minute Walk test). Age 18-65 SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D SCI ≥ 12months SCI lesion level T10 and above with preservation of conus function SCI due to trauma 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 Must provide and sign the Informed Consent prior to any study-related procedures Exclusion Criteria: 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 Any indication that would require diathermy Any indication that would require MRI Any anatomical limitations in the implantation area as judged by the investigators 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 Presence of indwelling baclofen or insulin pump 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 Enrolment of the investigator, his/her family members, employees, and other dependent persons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-site, single-arm, non-blinded, non-randomized, interventional
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Epidural Spinal Stimulation<br>Single arm study: the participants that have undergone the STIMO study 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<br>* The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion (expected 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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). | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months | 
| Quality of Life questionnaires | Questionnaires addressing bowel, bladder and sexual functions. | Monthly during the first year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCI, Spinal Cord Injury, Epidural Spinal Stimulation