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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| The Methodist Hospital Research Institute | OTHER |
| University of Pennsylvania | OTHER |
| University of Utah |
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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:
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:
Study Activities (including standard of care (SOC))
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with high-level SCI injury (C1-C4) with complete lack of upper extremity function. Occurrence of injury should be greater than 6 months but fewer than 60 months
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Koester, BS | Contact | 314-362-7368 | koesterl@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wilson Z. Ray, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| Washington University Neurosurgery Website | View source |
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Aggregate data will be shared
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| OTHER |
| Stanford University | OTHER |
| University of Miami | OTHER |
| Johns Hopkins University | OTHER |
| University of Alberta | OTHER |
| Wake Forest University Health Sciences | OTHER |
| Congressionally Directed Medical Research Programs | FED |
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| 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 |
| 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 |
| 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 |
| 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 |
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
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| Wake Forest Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Houston Methodist | Recruiting | Houston | Texas | 77030 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| University of Alberta | Not yet recruiting | Edmonton | Alberta | T6G-2E1 | Canada |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |