NCT05942339 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)
| NCT ID | NCT05942339 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8 participants in total. It began in 2023-08-30 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 9. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments 10. Must provide and sign the Informed Consent prior to any study-related procedures Exclusion Criteria: 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 9. Clinically significant mental illness in the judgement of the investigators 10. Presence of indwelling baclofen or insulin pump 11. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) 12. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant 13. Enrolment of the investigator, his/her family members, employees, and other dependent persons 14. Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
Contact & Investigator
Jocelyne Bloch, MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT05942339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05942339 currently recruiting?
Yes, NCT05942339 is actively recruiting participants. Contact the research team at gregoire.courtine@epfl.ch for enrollment information.
Where is the NCT05942339 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05942339 clinical trial?
NCT05942339 is sponsored by Ecole Polytechnique Fédérale de Lausanne. The principal investigator is Jocelyne Bloch, MD at CHUV. The trial plans to enroll 8 participants.