Epidural Stimulation for Upper Extremity Function

Официальное название

Spinal Cord Stimulation for Reanimation After Nervous System Injury

Обзор

Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life. At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients. The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.

Подробное описание

The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation.

At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested.

Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region.

Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented.

Temporary leads will be removed after approximately 4 weeks.

At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed.

Вмешательства

• Устройство Percutaneous spinal cord stimulation
  The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.

Первичные конечные точки

• Nerve transfer recipient muscle strength [Срок оценки: 0-6 weeks]

Вторичные конечные точки (5)

• Nerve transfer recipient muscle force [Срок оценки: 0-6 weeks]
• Neck and upper extremity pain [Срок оценки: 0-6 weeks]
• Amplitude of percutaneous stimulation [Срок оценки: 0-4 weeks]
• Frequency of percutaneous stimulation [Срок оценки: 0-4 weeks]
• Pulse width of percutaneous stimulation [Срок оценки: 0-4 weeks]

Критерии участия

Критерии включения

• Age ≥18 years and ≤65
• Provides informed consent
• History of upper extremity nerve transfer > 6 months prior to enrollment
• Completion of standard post-nerve transfer occupational therapy
• Baseline upper extremity strength of < 5/5 grade with the MRC
• Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy
• Willing and able to adhere to the study protocol

Критерии исключения

• Central nervous system (CNS) malignancy
• A contraindication to the SCS procedure
• Diagnosis that precludes the patient from full participation in the protocol
• A functional implanted device (pacemaker, vagus nerve device, baclofen pump)
• Botulinum toxin injection in upper extremity muscles < 6 months prior to enrollment
• For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)
• Other factors that prevent participation in the opinion of the surgeon-principal investigator

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

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Bertelli JA, Ghizoni MF. Nerve transfers for restoration of finger flexion in patients with tetraplegia. J Neurosurg Spine. 2017 Jan;26(1):55-61. doi: 10.3171/2016.5.SPINE151544. Epub 2016 Aug 5. PMID 27494781
• Fox IK. Nerve Transfers in Tetraplegia. Hand Clin. 2016 May;32(2):227-42. doi: 10.1016/j.hcl.2015.12.013. Epub 2016 Mar 10. PMID 27094894
• Lu DC, Edgerton VR, Modaber M, AuYong N, Morikawa E, Zdunowski S, Sarino ME, Sarrafzadeh M, Nuwer MR, Roy RR, Gerasimenko Y. Engaging Cervical Spinal Cord Networks to Reenable Volitional Control of Hand Function in Tetraplegic Patients. Neurorehabil Neural Repair. 2016 Nov;30(10):951-962. doi: 10.1177/1545968316644344. Epub 2016 May 18. PMID 27198185
• Barra B, Conti S, Perich MG, Zhuang K, Schiavone G, Fallegger F, Galan K, James ND, Barraud Q, Delacombaz M, Kaeser M, Rouiller EM, Milekovic T, Lacour S, Bloch J, Courtine G, Capogrosso M. Epidural electrical stimulation of the cervical dorsal roots restores voluntary upper limb control in paralyzed monkeys. Nat Neurosci. 2022 Jul;25(7):924-934. doi: 10.1038/s41593-022-01106-5. Epub 2022 Jun 30. PMID 35773543
• 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. PMID 33469022
• Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20. PMID 36807682

Идентификаторы

NCT: NCT06437548 · 2024P000185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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