Epidural Stimulation for Upper Extremity Function

Official title

Spinal Cord Stimulation for Reanimation After Nervous System Injury

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Nerve transfer recipient muscle strength [Time frame: 0-6 weeks]

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT06437548 · 2024P000185

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗