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Spinal implant system to support walking in people with long-term spinal cord injury

Tests a new spinal stimulation system for movement in adults with spinal cord injury.

Key facts

Who runs it
Ecole Polytechnique Fédérale de Lausanne
Where
Lausanne, SwitzerlandSee the site
Trial code
Registry 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 (BoxSwitch)
Status
Recruiting
People taking part
8 people, planned
Started
30 Aug 2023
Expected to end
30 Aug 2027
Type of study
Interventional
Treatments tested
  • Procedure/Surgery
Record updated
11 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a long-standing spinal cord injury from trauma who already have an implanted spinal stimulation system. They would swap it for the new ARC-IM Lumbar system.

Age
18 to 65 years
Sex
All sexes
Disease stage
Spinal cord injury graded AIS A, B, C or D, for at least 12 months. Injury level T10 or higher, with the lowest end of the spinal cord (conus) still working. Injury must be caused by trauma.
Earlier treatment
Must already have an implanted spinal array (Specify 5-6-5 or Go2 Lead) for leg movement, for example from the STIMO study (NCT02936453) or similar studies.

Main reasons for not taking part

  • Heart attack or stroke in the past 6 months
  • An active implanted heart device such as a pacemaker or defibrillator
  • Needing MRI or diathermy (heat treatment)
  • An implanted baclofen or insulin pump
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings
  • Age 18-65
  • SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D
  • SCI ≥ 12months
  • SCI lesion level T10 and above with preservation of conus function
  • SCI due to trauma
  • Stable medical, physical and psychological condition as considered by the investigators
  • Able to understand and interact with the study team in French or English
  • Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
  • Must provide and sign the Informed Consent prior to any study-related procedures

Who cannot take part

  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
  • History of myocardial infarction or cerebrovascular event within the past 6 months
  • Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
  • Any active implanted cardiac device such as pacemaker or defibrillator
  • Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
  • Clinically significant mental illness in the judgement of the investigators
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
  • Any indication that would require diathermy
  • Any indication that would require MRI
  • Any anatomical limitations in the implantation area as judged by the investigators
  • Presence of indwelling baclofen or insulin pump
  • Enrolment of the investigator, his/her family members, employees, and other dependent persons
  • Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Switzerland

  • CHUVLausanne, SwitzerlandContact: Jocelyne Dr Bloch, Prof. Dr.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The group in the trial

  • Targeted Epidural Spinal StimulationTreatment being tested

    Single arm study: the participants who have previously received a spinal array and an implantable pulse generator either through the STIMO study or similar studies conducted abroad will be proposed to exchange their currently implanted system with selected components from the ARC-IM Lumbar system. After the surgery, the participants will perform around 20 optimization sessions that may include rehabilitation to configure the neuromodulation system. Then the participants will use the ARC-IM Lumbar system independently during daily life activities until the end of the 36 months post-surgery. Assessments will be planned throughout the course of the study at the end of the optimization phase, after 12 and 24 months post-surgery and at the end of the study, with and/or stimulation.

    Treatment: Procedure/Surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Spinal implant system to support walking in people with long-term spinal cord injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05942339, who can take part
Record updated
11 December 2025