Spinal Cord Injury Cervical, Tetraplegia
Conditions
Keywords
spinal, cord, stimulation, percutaneous, peripheral, nerve, transfer
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.
Interventions
DEVICEPercutaneous spinal cord stimulation
The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nerve transfer recipient muscle strength | 0-6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nerve transfer recipient muscle force | 0-6 weeks | 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. |
| Neck and upper extremity pain | 0-6 weeks | 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. |
| Amplitude of percutaneous stimulation | 0-4 weeks | Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes. |
| Frequency of percutaneous stimulation | 0-4 weeks | 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). |
| Pulse width of percutaneous stimulation | 0-4 weeks | 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. |
Contacts
Primary ContactBenjamin R. Johnston, MD PhD
Backup ContactJoshua I. Chalif, MD PhD
Outcome results
None listed