Percutaneous spinal cord stimulation
DeviceThe parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.
NCT Number: NCT06437548
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Benjamin R. Johnston, MD PhD
CONTACT
Joshua I. Chalif, MD PhD
CONTACT
Brigham and Women's Hospital
Other
Spinal Cord Stimulation for Reanimation After Nervous System Injury
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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