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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 acronym: BoxSwitch
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 3 words
    • Study description expanded, about 4 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 2027 to Aug 30, 2027
    • Start date changed from estimate of Aug 2023 to Aug 30, 2023
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05942339
Lead Sponsor Ecole Polytechnique Fédérale de Lausanne
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Spinal Cord Injuries
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov