Nerve Transfer to Improve Function in High Level Tetraplegia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Elbow Dynamometry
Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer
Time frame
36-48 months post-surgery2
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.
Time frame
36-48 months post-surgery3
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.
Time frame
36-48 months post-surgery4
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.
Time frame
36-48 months post-surgerySecondary outcomes
1
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.
Time frame
36-48 Months post-surgery2
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.
Time frame
36-48 Months post-surgery3
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.
Time frame
36-48 Months post-surgery4
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..
Time frame
36-48 Months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
University of Michigan
Collaborator
The Methodist Hospital Research Institute
Collaborator
University of Pennsylvania
Collaborator
University of Utah
Collaborator
Stanford University
Collaborator
University of Miami
Collaborator
Johns Hopkins University
Collaborator
University of Alberta
Collaborator
Wake Forest University Health Sciences
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov