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Spinal Cord Stimulation for Reanimation After Nervous System Injury
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 1, 2024
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2027
Last Updated
May 31, 2024
20
ESTIMATED participants
Percutaneous spinal cord stimulation
DEVICE
Lead Sponsor
Brigham and Women's Hospital
NCT06611748
NCT06841770
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06814015