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RECRUITING

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)

Sponsor: Ecole Polytechnique Fédérale de Lausanne

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-08-30

Completion Date

2027-08-30

Last Updated

2025-12-11

Healthy Volunteers

Conditions

Spinal Cord Injuries

Interventions

DEVICE

Procedure/Surgery

The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

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

Locations (1)

CHUV

Lausanne, Canton of Vaud, Switzerland