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)
Eligible age
18–65 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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).
Sponsor: Ecole Polytechnique Fédérale de Lausanne
You may qualify if…
- ✓ 1. Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
- ✓ 2. Age 18-65
- ✓ 3. SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D
- ✓ 4. SCI ≥ 12months
- ✓ 5. SCI lesion level T10 and above with preservation of conus function
- ✓ 6. SCI due to trauma
- ✓ 7. Stable medical, physical and psychological condition as considered by the investigators
- ✓ 8. Able to understand and interact with the study team in French or English
You may not qualify if…
- ✕ 1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- ✕ 2. History of myocardial infarction or cerebrovascular event within the past 6 months
- ✕ 3. Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
- ✕ 4. Any active implanted cardiac device such as pacemaker or defibrillator
- ✕ 5. Any indication that would require diathermy
- ✕ 6. Any indication that would require MRI
- ✕ 7. Any anatomical limitations in the implantation area as judged by the investigators
- ✕ 8. Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
Source: ClinicalTrials.gov · NCT05942339 · last updated 2025-12-11