Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288763
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-02-23
Brief Title:
Nerve Transfer to Improve Function in High Level Tetraplegia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury
Participants will
undergo standard of care pre- and post-op testing and study exams
complete pre- and post-questionnaires
undergo standard of care nerve transfer surgeries
follow-up with surgeon at 612182436 and potentially at 48 months
attend therapy at local therapist for up to 2 years postop
Participants will
undergo standard of care pre- and post-op testing and study exams
complete pre- and post-questionnaires
undergo standard of care nerve transfer surgeries
follow-up with surgeon at 612182436 and potentially at 48 months
attend therapy at local therapist for up to 2 years postop
Detailed Description:
Restoration of function in patients with high tetraplegia has been an elusive clinical challenge There is a critical need to find an effective reconstructive therapyprocedure which improves the upper extremity function in patients with high tetraplegia
One pure motor nerve - spinal accessory nerve SAN remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension Elbow function can provide profound independence in mobility ventilator management and may broaden the application of assistive therapies
The two objectives of this study are
Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients
Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia
Study Activities including standard of care SOC
Electrodiagnosis pre-op SOC
Upper extremity maximum muscle testing SOC
Questionnaires SOC and study-related SR
Exams by a study therapist SR
Neurological exam - ISNCSCI - SOC
Nerve Transfer Surgery to be determined by surgeon SOC
Follow-up visits with surgeon at 612182436 and potentially 48 months
post-op electrodiagnostic testing SR
post-op upper extremity maximum muscle testing SOC
post-op questionnaires
post-op therapy exams SR
One pure motor nerve - spinal accessory nerve SAN remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension Elbow function can provide profound independence in mobility ventilator management and may broaden the application of assistive therapies
The two objectives of this study are
Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients
Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia
Study Activities including standard of care SOC
Electrodiagnosis pre-op SOC
Upper extremity maximum muscle testing SOC
Questionnaires SOC and study-related SR
Exams by a study therapist SR
Neurological exam - ISNCSCI - SOC
Nerve Transfer Surgery to be determined by surgeon SOC
Follow-up visits with surgeon at 612182436 and potentially 48 months
post-op electrodiagnostic testing SR
post-op upper extremity maximum muscle testing SOC
post-op questionnaires
post-op therapy exams SR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None