Nerve Transfer to Improve Function in High Level Tetraplegia

Recruiting

• Conditions: Cervical Spinal Cord Injury; Tetraplegia

• Registration Number: NCT06288763
• Lead Sponsor: Washington University School of Medicine

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
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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 therapy/procedure which improves the upper extremity function in patients with high tetraplegia.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-02-05
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2028-03-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor strength in medical research council grade (MRC)	36-48 months post-surgery	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.
Elbow Dynamometry	36-48 months post-surgery	Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer
Spinal Cord Independence Measure	36-48 months post-surgery	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/objective...
Electrodiagnosis (Nerve Conduction Study and Electromyography	36-48 months post-surgery	Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS)	36-48 Months post-surgery	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.
Canadian Outcomes Performance Measure (COPM)	36-48 Months post-surgery	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.
Capabilities of Upper Extremity Questionnaire (CUE-Q)	36-48 Months post-surgery	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.
Spinal Cord Injury Quality of LIfe Questionnaire	36-48 Months post-surgery	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..
International SCI Pain Basic Dataset (ISCIPBDS)	36-48 Months post-surgery	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.

Trial Locations

Locations (10)

Stanford University; 🇺🇸 Stanford, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Calgary - Alberta Health Services; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada