Nerve Transfer to Improve Function in High Level Tetraplegia

Tetraplegia Clinical Trial

Official title:

Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288763
• Other study ID #: SC220192
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Linda Koester, BS
• Phone: 314-362-7368
• Email: koesterl[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 6/12/18/24/36 and potentially at 48 months - attend therapy at local therapist for up to 2 years postop.

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 therapy/procedure 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 6/12/18/24/36 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years of age
• High cervical SCI (motor level C1-C4)
• Motor complete SCI AIS grade A-B
• Plateaued spontaneous recovery for at least 6 months of non-operative therapy
• SCI greater than 6 months and fewer than 60 months since injury
• At least MRC 4/5 donor strength
• Mentally and physically willing and able to comply with evaluations

Exclusion Criteria:

• Active infection at the operative site or systemic infection
• Any return or ongoing recovery of distal motor function
• Significant joint contractures and/or limitations in passive range of motion in the arm
• Mentally or physically compromised making it impossible to complete study activities
• Immunologically suppressed
• Currently undergoing long-term steroid therapy
• Active malignancy
• Pregnancy

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia

Locations

Country	Name	City	State
Canada	University of Calgary - Alberta Health Services	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Houston Methodist	Houston	Texas
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (10)

Lead Sponsor	Collaborator
Washington University School of Medicine	Johns Hopkins University, Stanford University, The Methodist Hospital Research Institute, University of Alberta, University of Calgary, University of Miami, University of Michigan, University of Pennsylvania, University of Utah

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elbow Dynamometry	Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer	36-48 months post-surgery
Primary	Spinal Cord Independence Measure	Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors/outdoors). SCIM guide clinicians in determining treatment goals/objectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function.	36-48 months post-surgery
Primary	Motor strength in medical research council grade (MRC)	Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score.	36-48 months post-surgery
Primary	Electrodiagnosis (Nerve Conduction Study and Electromyography	Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.	36-48 months post-surgery
Secondary	Canadian Outcomes Performance Measure (COPM)	Change from baseline to 36-48 months post-surgery. COPM is a validated outcome measure for SCI patients focusing on occupational performance in all areas of life. Scores range from 5-50 for performance and satisfaction. The higher scores reflect better performance and satisfaction.	36-48 Months post-surgery
Secondary	Capabilities of Upper Extremity Questionnaire (CUE-Q)	Change from baseline to 36-48 months post-surgery. CUE-Q detects changes in upper extremity function. Scores range from 32-224 with higher scores reflecting better function.	36-48 Months post-surgery
Secondary	Modified Ashworth Scale (MAS)	Change from baseline to 36-48 months post-surgery. MAS is a reliable measure for rating spasticity in SCI. Scores range from 0-32 with higher scores reflecting better function.	36-48 Months post-surgery
Secondary	Spinal Cord Injury Quality of LIfe Questionnaire	Change from baseline to 36-48 months post-surgery. SCI-QOL is designed to measure subjective quality of life in terms of satisfaction and importance. Range of scores is 0 to 30 with the higher scores reflecting a better quality of life..	36-48 Months post-surgery
Secondary	International SCI Pain Basic Dataset (ISCIPBDS)	Change from baseline to 36-48 months post-surgery. ISCIPBDS correctly classifies pain, determines its intensity and broad impact on daily activities. Lower scores reflect less pain/less interference in daily life.	36-48 Months post-surgery

External Links

•   Washington University Neurosurgery Website