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 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
Ecole Polytechnique Fédérale de Lausanne
8 participants
Aug 30, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria10
- 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
- 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 Criteria14
- 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
- Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
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Interventions
The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05942339