Clinical trial NCT06437548: Epidural Stimulation for Upper Extremity Function
Official title: Spinal Cord Stimulation for Reanimation After Nervous System Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury Cervical
Tetraplegia
Keywords: spinal
cord
stimulation
percutaneous
peripheral
nerve
transfer
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Nerve transfer recipient muscle strength
timeFrame: 0-6 weeks
Secondary outcomes:
measure: Nerve transfer recipient muscle force
timeFrame: 0-6 weeks
measure: Neck and upper extremity pain
timeFrame: 0-6 weeks
measure: Amplitude of percutaneous stimulation
timeFrame: 0-4 weeks
measure: Frequency of percutaneous stimulation
timeFrame: 0-4 weeks
measure: Pulse width of percutaneous stimulation
timeFrame: 0-4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Yi Lu, MD PhD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
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.
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.