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)

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Устройство Procedure/Surgery
  The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

Первичные конечные точки

• Preliminary safety of the ARC Therapy [Срок оценки: Through study completion (expected 3 years)]

Вторичные конечные точки (9)

• 10 Meters Walk test (m/s) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• 6 Minutes Walk test (meters) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• International Standards For Neurological Classification of Spinal Injury (ISNCSCI) [Срок оценки: Baseline, 12 months, 24 months and 36 months]
• Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• Neuromuscular Recovery Scale (NRS) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• Walking Index for Spinal Cord Injury (WISCI II) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• Modified Ashworth Scale (MAS) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• Spinal Cord Independence Measure (SCIM III) [Срок оценки: Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months]
• Quality of Life questionnaires [Срок оценки: Monthly during the first year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• CHUV — Lausanne

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 36352232

Идентификаторы

NCT: NCT05942339 · BOX2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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