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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Epidural Spinal Stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Surgery | Device | The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion (expected 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| 6 Minutes Walk test (meters) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégoire Courtine, Prof | Contact | +41 21 69 30762 | gregoire.courtine@epfl.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jocelyne Bloch, MD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUV | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15672628 | Background | 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. | |
| 23884034 | Background | 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. |
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Single-site, single-arm, non-blinded, non-randomized, interventional
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The 6 minutes walk test is a performance measureused to assess aerobic capacity and endurance. |
| Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| International Standards For Neurological Classification of Spinal Injury (ISNCSCI) | A neurological assessment and classification of a spinal cord injury | Baseline, 12 months, 24 months and 36 months |
| Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) | The SCI-FAI assesses functional walking ability in ambulatory individuals with SCI. | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| 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. | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| 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. | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| Modified Ashworth Scale (MAS) | The modified Ashworth scale a universally accepted clinical tool used to measure the increase of muscle tone. | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| Spinal Cord Independence Measure (SCIM III) | The SCIM address specific areas of function in patients with spinal cord injuries (SCI). | Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months |
| Quality of Life questionnaires | Questionnaires addressing bowel, bladder and sexual functions. | Monthly during the first year |
| 29459943 | Background | 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. |
| 26931074 | Background | 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. |
| 19406310 | Background | 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. |
| 30382196 | Background | 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. |
| 25962761 | Background | 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. |
| 36352232 | Background | 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. |
| 16304564 | Background | 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. |
| 32690972 | Background | 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. |
| 34172974 | Background | 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. |
| 34584091 | Background | 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. |
| 33328910 | Background | 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. |
| 24248345 | Background | 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. |
| 27339989 | Background | 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. |
| 30948552 | Background | Maniatis S, Aijo T, Vickovic S, Braine C, Kang K, Mollbrink A, Fagegaltier D, Andrusivova Z, Saarenpaa S, Saiz-Castro G, Cuevas M, Watters A, Lundeberg J, Bonneau R, Phatnani H. Spatiotemporal dynamics of molecular pathology in amyotrophic lateral sclerosis. Science. 2019 Apr 5;364(6435):89-93. doi: 10.1126/science.aav9776. |
| 27365449 | Background | Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403. |
| 29556028 | Background | Asboth L, Friedli L, Beauparlant J, Martinez-Gonzalez C, Anil S, Rey E, Baud L, Pidpruzhnykova G, Anderson MA, Shkorbatova P, Batti L, Pages S, Kreider J, Schneider BL, Barraud Q, Courtine G. Cortico-reticulo-spinal circuit reorganization enables functional recovery after severe spinal cord contusion. Nat Neurosci. 2018 Apr;21(4):576-588. doi: 10.1038/s41593-018-0093-5. Epub 2018 Mar 19. |
| 28724575 | Background | Mignardot JB, Le Goff CG, van den Brand R, Capogrosso M, Fumeaux N, Vallery H, Anil S, Lanini J, Fodor I, Eberle G, Ijspeert A, Schurch B, Curt A, Carda S, Bloch J, von Zitzewitz J, Courtine G. A multidirectional gravity-assist algorithm that enhances locomotor control in patients with stroke or spinal cord injury. Sci Transl Med. 2017 Jul 19;9(399):eaah3621. doi: 10.1126/scitranslmed.aah3621. |
| 30382197 | Background | Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31. |
| 22897489 | Background | Phillips AA, Krassioukov AV, Ainslie PN, Warburton DE. Baroreflex function after spinal cord injury. J Neurotrauma. 2012 Oct 10;29(15):2431-45. doi: 10.1089/neu.2012.2507. Epub 2012 Sep 20. |
| 35132264 | Background | Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7. |
| 24305828 | Background | Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013. |
| 33469022 | Background | Greiner N, Barra B, Schiavone G, Lorach H, James N, Conti S, Kaeser M, Fallegger F, Borgognon S, Lacour S, Bloch J, Courtine G, Capogrosso M. Recruitment of upper-limb motoneurons with epidural electrical stimulation of the cervical spinal cord. Nat Commun. 2021 Jan 19;12(1):435. doi: 10.1038/s41467-020-20703-1. |
| 26853304 | Background | Moraud EM, Capogrosso M, Formento E, Wenger N, DiGiovanna J, Courtine G, Micera S. Mechanisms Underlying the Neuromodulation of Spinal Circuits for Correcting Gait and Balance Deficits after Spinal Cord Injury. Neuron. 2016 Feb 17;89(4):814-28. doi: 10.1016/j.neuron.2016.01.009. Epub 2016 Feb 4. |
| 22464657 | Background | Minassian K, Hofstoetter U, Tansey K, Mayr W. Neuromodulation of lower limb motor control in restorative neurology. Clin Neurol Neurosurg. 2012 Jun;114(5):489-97. doi: 10.1016/j.clineuro.2012.03.013. Epub 2012 Mar 29. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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