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)

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Ecole Polytechnique Fédérale de Lausanne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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. Patients who previously received an implantation in international studies for continuous electrical stimulation can enroll 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).

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Procedure/Surgery	The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

Timeline

• Start date: 2023-08-30
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2023-07-12
• Last updated: 2025-12-11

Locations

1 site across 1 country: Switzerland