Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-25
Brief Title:
Epidural Stimulation for Upper Extremity Function
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Spinal Cord Stimulation for Reanimation After Nervous System Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 strengthforce 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
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 strengthforce 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None