ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury

Обзор

The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.

Вмешательства

• Устройство ARC-IM Therapy
  All participants will be treated with ARC-IM Therapy. The ARC-IM Lumbar System is intended to deliver electrical impulses to the lumbosacral region of the spinal cord to support ambulatory functions in people with SCI.

Первичные конечные точки

• Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to ARC-IM Therapy, from implantation up to the end of the study. [Срок оценки: Continuously throughout the study (up to 6 years)]

Вторичные конечные точки (9)

• American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) [Срок оценки: At Eligibility, and at 6 weeks, 16 weeks, 42 weeks post-surgery]
• 10-Meter Walk Test (10MWT) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, ad 42 weeks post-surgery]
• 6-Minute Walk Test (6MWT) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Timed Up and Go (TUG) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Walking Index for Spinal Cord Injury version II (WISCI II) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Gait Analysis [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Goal Attainment Scale (GAS) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery]
• Berg Balance Scale (BBS) [Срок оценки: At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery]

Критерии участия

Критерии включения

• Must be at least 18 years old and no older than 65 years old at the time of enrollment.
• Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).
• Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI.
• Must have sustained their injury either less than 6 weeks prior to baseline (Group "Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI").
• Must be suffering from a SCI due to trauma.
• Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.
• Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).
• Must be able to understand and interact with the study team in German, French or English.
• Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.
• Must provide Informed Consent as documented by signature prior to any study-related procedures.
• Must have an acceptable or highly effective method of contraception for women of childbearing capacity.

Критерии исключения

• Must not be pregnant nor breastfeeding.
• Must not have brain damage.
• Must not have a history of epilepsy
• Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.
• Must not have previously been injected with stem cells in the spinal cord.
• Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.
• Must not require ventilator support.
• Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).
• Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.).
• Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation).
• Must not require the use of an intrathecal baclofen pump.
• Must not have any active implanted devices.
• Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
• Must not be the investigator him/herself, his/her family members, employees or other dependent persons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• Schweizer Paraplegiker-Zentrum (SPZ) — Nottwil
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne

Публикации

• 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. PMID 24305828
• 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
• 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 PMID 30382197
• 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 PMID 35132264

Идентификаторы

NCT: NCT07234903 · EIGER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗