Epidural Stimulation for Upper Extremity Function

Tetraplegia Clinical Trial

Official title:

Spinal Cord Stimulation for Reanimation After Nervous System Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437548
• Other study ID #: 2024P000185
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Benjamin R. Johnston, MD PhD
• Phone: (617) 525-7378
• Email: bjohnston2[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury Cervical
• Tetraplegia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve transfer recipient muscle strength	Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome.	0-6 weeks
Secondary	Nerve transfer recipient muscle force	Change in muscle force generated by recipient nerve transfer muscle group with spinal cord stimulation activated. Muscle force is measured with a hand-held dynamometer. This is measured in Newtons, with a larger number meaning greater force and a better outcome.	0-6 weeks
Secondary	Neck and upper extremity pain	Change in neck and upper extremity pain measured with the Numeric Rating Scale (NRS). NRS scale ranges from 0 (No pain) to 10 (worst possible pain), with a lower number representing a better outcome. A positive change in NRS from baseline to follow-up visits suggests improvement of pain.	0-6 weeks
Secondary	Amplitude of percutaneous stimulation	Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes.	0-4 weeks
Secondary	Frequency of percutaneous stimulation	Optimized frequency of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Frequency is measured in Hz (Hertz).	0-4 weeks
Secondary	Pulse width of percutaneous stimulation	Optimized pulse width of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Pulse width is measured in microseconds.	0-4 weeks