Epidural Stimulation for Upper Extremity Function

NCT06437548 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024P000185
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spinal Cord Injury Cervical; Tetraplegia

Keywords

spinal; cord; stimulation; percutaneous; peripheral; nerve; transfer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nerve transfer recipient muscle force

  0-6 weeks

• Neck and upper extremity pain

  0-6 weeks

• Amplitude of percutaneous stimulation

  0-4 weeks

• Frequency of percutaneous stimulation

  0-4 weeks

• Pulse width of percutaneous stimulation

  0-4 weeks

Study Arms (1)

Percutaneous spinal cord stimulation

EXPERIMENTAL

All participants will undergo baseline muscle strength and force assessments. Participants will also answer questionnaires on pain and quality of life. An optional nerve health assessment with needle electromyography and neuroimaging may be performed. Participants will undergo clinically indicated percutaneous (temporal) cervical epidural leads placement. Weeks 0-4 post-leads placement: during weekly visits upper extremity muscle strength and force will be assessed, pain and quality of life questionnaires will be completed (1 research visit per week) At approximately 28 days temporary leads will be removed. At the last visit, muscle strength and force in upper extremity muscle groups will be assessed, participants will complete pain and quality of life questionnaires. Participants may choose to undergo an optional nerve health assessment with needle electromyography and neuroimaging.

Device: Percutaneous spinal cord stimulation

Interventions

Percutaneous spinal cord stimulation DEVICE

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

Percutaneous spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Quadriplegia; Cone-Rod Dystrophies

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yi Lu, MD PhD

  Brigham and Women's Hospital

  STUDY CHAIR

Central Study Contacts

Benjamin R. Johnston, MD PhD

CONTACT

(617) 525-7378; bjohnston2@mgb.org

Joshua I. Chalif, MD PhD

CONTACT

(617) 525-7378; jchalif@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurosurgical Trauma, Associate Professor of Neurosurgery

Model Details: Percutaneous temporary spinal cord stimulator. Parameters for upper extremity motor function will be assessed with the stimulation turned on and off. Muscle strength and force will be assessed with the stim turned on and off.

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share