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) — BoxSwitch  

Spinal Cord Injuries Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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 with chronic spinal cord injury. Only participants that have undergone the STIMO study (NCT02936453) 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).

Clinical Trial Description

Studies have shown that using Electrical Epidural Stimulation (EES) could improve considerably the functional movements after paralyzing SCI. In the STIMO study (NCT02936453), the investigational system was mainly composed of medical devices developed for other indications and used off-label, allowing only a limited tuning of EES protocols. To overcome this limitation, we propose to conduct a study in which a new platform will be investigated. This new therapy, named ARC Therapy, features the ARC-IM implantable pulse generator with an optimized communication system and the ARC-IM implantable leads supporting stimulation protocols specifically developed for effective activation of motor neurons.

The study will take place at the CHUV (Lausanne, Switzerland). A maximum of 8 participants will be enrolled in the study and implanted with an ARC-IM IPG. Only participants that have undergone the STIMO protocol (NCT02936453) can enrol in the current BoxSwitch study. Replacement of their currently implanted IPG and lead will be assessed on a case-by-case manner considering current status of their implanted devices, technical and surgical compatibility with the newly proposed ARC-IM Lumbar system components.

The study intervention consists of several phases preceded by pre-screening:

Screening and enrollment, baseline and pre-implantation assessments, surgery, optimization phase, short-term assessments, independent use phase and follow-up assessments at months 12, 24 and 36. Measures will be performed before surgical intervention and at regular intervals during the study.

The total duration of the study will be approximately 48 months (up to 36 months/participant). ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT05942339
• Study type: Interventional
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: Grégoire Courtine, Prof
• Phone: +41 21 69 30762
• Email: gregoire.courtine@epfl.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Completion date: August 2027