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Spinal Cord InjuriesBoxSwitchNCT05942339

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)

A study testing Procedure/Surgery in people with Spinal Cord Injuries, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Procedure/Surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSwitzerland
Study dates
30 Aug 2023to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 join

  • 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
  • Any indication that would require diathermy
  • Any indication that would require MRI
Show all 14Show fewer
  • Any anatomical limitations in the implantation area as judged by the investigators
  • 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
  • Presence of indwelling baclofen or insulin pump
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grégoire Courtine, Prof contact

+41 21 69 30762

gregoire.courtine@epfl.ch

Switzerland1 site, 1 recruiting

  • CHUV

    Lausanne, Canton of Vaud, 1011

    Jocelyne Dr Bloch, Prof. Dr.

    Recruiting

Other trials in Switzerland

About this study

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

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).

Read the 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).

Being tested
Procedure/Surgery
Keywords
SCI, Spinal Cord Injury, Epidural Spinal Stimulation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure/SurgeryDevice

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

Study groups in NCT05942339
Study groupRoleWhat they receive
Targeted Epidural Spinal StimulationExperimentalSingle 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.
Receives: Device: Procedure/Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preliminary safety of the ARC Therapy

    Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.

    Measured: Through study completion (expected 3 years)

Secondary outcomes (9)

  1. 10 Meters Walk test (m/s)

    The 10 Meters Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  2. 6 Minutes Walk test (meters)

    The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  3. International Standards For Neurological Classification of Spinal Injury (ISNCSCI)

    A neurological assessment and classification of a spinal cord injury

    Measured: Baseline, 12 months, 24 months and 36 months

  4. Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

    The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  5. Neuromuscular Recovery Scale (NRS)

    The NRS is used to measure quality of movement without compensatory movement patterns using a body weight support system and a treadmill.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  6. Walking Index for Spinal Cord Injury (WISCI II)

    The Walking Index for Spinal Cord Injury (WISCI) is a scale that measures the type and amount of assistance (in terms of requirements of assistive devices, or human helpers) required by a person with spinal cord injury (SCI) for walking.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  7. Modified Ashworth Scale (MAS)

    The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone.

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  8. Spinal Cord Independence Measure (SCIM III)

    The SCIM address specific areas of function in patients with spinal cord injuries (SCI).

    Measured: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

  9. Quality of Life questionnaires

    Questionnaires addressing bowel, bladder and sexual functions.

    Measured: Monthly during the first year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start30 Aug 2023
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-site, single-arm, non-blinded, non-randomized, interventional
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05942339
Sponsor's protocol ID
BOX2023
Acronym
BoxSwitch
Status last verified
Dec 2025
First submitted
12 Jun 2023
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.

    PubMed 15672628

  • Cragg JJ, Noonan VK, Krassioukov A, Borisoff J. Cardiovascular disease and spinal cord injury: results from a national population health survey. Neurology. 2013 Aug 20;81(8):723-8. doi: 10.1212/WNL.0b013e3182a1aa68. Epub 2013 Jul 24.

    PubMed 23884034

  • West CR, Phillips AA, Squair JW, Williams AM, Walter M, Lam T, Krassioukov AV. Association of Epidural Stimulation With Cardiovascular Function in an Individual With Spinal Cord Injury. JAMA Neurol. 2018 May 1;75(5):630-632. doi: 10.1001/jamaneurol.2017.5055.

    PubMed 29459943

  • Brinkhof MW, Al-Khodairy A, Eriks-Hoogland I, Fekete C, Hinrichs T, Hund-Georgiadis M, Meier S, Scheel-Sailer A, Schubert M, Reinhardt JD; SwiSCI Study Group. Health conditions in people with spinal cord injury: Contemporary evidence from a population-based community survey in Switzerland. J Rehabil Med. 2016 Feb;48(2):197-209. doi: 10.2340/16501977-2039.

    PubMed 26931074

  • Krassioukov A, Eng JJ, Warburton DE, Teasell R; Spinal Cord Injury Rehabilitation Evidence Research Team. A systematic review of the management of orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2009 May;90(5):876-85. doi: 10.1016/j.apmr.2009.01.009.

    PubMed 19406310

  • Formento E, Minassian K, Wagner F, Mignardot JB, Le Goff-Mignardot CG, Rowald A, Bloch J, Micera S, Capogrosso M, Courtine G. Electrical spinal cord stimulation must preserve proprioception to enable locomotion in humans with spinal cord injury. Nat Neurosci. 2018 Dec;21(12):1728-1741. doi: 10.1038/s41593-018-0262-6. Epub 2018 Oct 31.

    PubMed 30382196

  • Phillips AA, Krassioukov AV. Contemporary Cardiovascular Concerns after Spinal Cord Injury: Mechanisms, Maladaptations, and Management. J Neurotrauma. 2015 Dec 15;32(24):1927-42. doi: 10.1089/neu.2015.3903. Epub 2015 Sep 1.

    PubMed 25962761

  • Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.

    PubMed 36352232

  • Claydon VE, Steeves JD, Krassioukov A. Orthostatic hypotension following spinal cord injury: understanding clinical pathophysiology. Spinal Cord. 2006 Jun;44(6):341-51. doi: 10.1038/sj.sc.3101855. Epub 2005 Nov 22.

    PubMed 16304564

  • Skinnider MA, Squair JW, Kathe C, Anderson MA, Gautier M, Matson KJE, Milano M, Hutson TH, Barraud Q, Phillips AA, Foster LJ, La Manno G, Levine AJ, Courtine G. Cell type prioritization in single-cell data. Nat Biotechnol. 2021 Jan;39(1):30-34. doi: 10.1038/s41587-020-0605-1. Epub 2020 Jul 20.

    PubMed 32690972

  • Squair JW, Skinnider MA, Gautier M, Foster LJ, Courtine G. Prioritization of cell types responsive to biological perturbations in single-cell data with Augur. Nat Protoc. 2021 Aug;16(8):3836-3873. doi: 10.1038/s41596-021-00561-x. Epub 2021 Jun 25.

    PubMed 34172974

  • Squair JW, Gautier M, Kathe C, Anderson MA, James ND, Hutson TH, Hudelle R, Qaiser T, Matson KJE, Barraud Q, Levine AJ, La Manno G, Skinnider MA, Courtine G. Confronting false discoveries in single-cell differential expression. Nat Commun. 2021 Sep 28;12(1):5692. doi: 10.1038/s41467-021-25960-2.

    PubMed 34584091

  • Gill M, Linde M, Fautsch K, Hale R, Lopez C, Veith D, Calvert J, Beck L, Garlanger K, Edgerton R, Sayenko D, Lavrov I, Thoreson A, Grahn P, Zhao K. Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe Thoracic Spinal Cord Injury. Front Syst Neurosci. 2020 Nov 19;14:79. doi: 10.3389/fnsys.2020.569337. eCollection 2020.

    PubMed 33328910

  • Grindberg RV, Yee-Greenbaum JL, McConnell MJ, Novotny M, O'Shaughnessy AL, Lambert GM, Arauzo-Bravo MJ, Lee J, Fishman M, Robbins GE, Lin X, Venepally P, Badger JH, Galbraith DW, Gage FH, Lasken RS. RNA-sequencing from single nuclei. Proc Natl Acad Sci U S A. 2013 Dec 3;110(49):19802-7. doi: 10.1073/pnas.1319700110. Epub 2013 Nov 18.

    PubMed 24248345

  • Lake BB, Ai R, Kaeser GE, Salathia NS, Yung YC, Liu R, Wildberg A, Gao D, Fung HL, Chen S, Vijayaraghavan R, Wong J, Chen A, Sheng X, Kaper F, Shen R, Ronaghi M, Fan JB, Wang W, Chun J, Zhang K. Neuronal subtypes and diversity revealed by single-nucleus RNA sequencing of the human brain. Science. 2016 Jun 24;352(6293):1586-90. doi: 10.1126/science.aaf1204.

    PubMed 27339989

Questions about this trial

What is this clinical trial studying?

A study testing Procedure/Surgery in people with Spinal Cord Injuries, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grégoire Courtine, Prof (+41 21 69 30762, gregoire.courtine@epfl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preliminary safety of the ARC Therapy (time frame: Through study completion (expected 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05942339, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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