Actively Recruiting
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)
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-12-11
8
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, confirmed by imaging, videos, or neurophysiology recordings
- Age between 18 and 65 years
- Spinal cord injury graded as AIS A, B, C, or D
- Spinal cord injury duration of 12 months or more
- Spinal cord injury lesion at T10 level or above with preserved conus function
- Spinal cord injury caused by trauma
- Stable medical, physical, and psychological condition as judged by investigators
- Ability to understand and interact with the study team in French or English
- Agreement to comply with study conditions and attend all appointments
- Signed informed consent prior to any study procedures
You will not qualify if you...
- Diseases or conditions increasing morbidity or mortality risk with spinal cord injury surgery
- History of heart attack or stroke within the past 6 months
- Walking function limited by other central nervous system disorders or systemic malignant or cardiovascular diseases
- Presence of active implanted cardiac devices like pacemaker or defibrillator
- Need for diathermy treatment
- Need for MRI scans
- Anatomical limitations in implantation area as judged by investigators
- Conditions preventing participation in testing as judged by investigators
- Clinically significant mental illness as judged by investigators
- Presence of indwelling baclofen or insulin pump
- Other significant diseases such as kidney, liver, or cardiovascular disease
- Inability to follow study procedures due to language, psychological disorders, or dementia
- Enrollment of investigators, their family members, employees, or dependents
- Women who are pregnant or breastfeeding (pregnancy test required for women of childbearing potential)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
G
Grégoire Courtine, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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