Incomplete Cervical SCI Without Instability

Study Overview
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Brief Summary
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A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.

Detailed Description
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This prospective multicenter study will enroll 50 adult patients with acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only without biomechanical instability. Patients will be assessed at the baseline visit and subsequently be followed up at 3 and 6 months. All decisions regarding the treatment and clinical management will be left to the attending spinal surgeon and will follow the local standard of care. The core outcome assessments include: Neurological status by the ISNCSCI Patient-reported outcome measures (PROMs) of Short Form-36 (SF-36) v2 and Neuropathic Pain Scale (NPS) The Spinal Cord Independence Measure (SCIM) v3 Gait and balance evaluated using the ten-meter walk test (10mWT) and Walking Index for Spinal Cord Injury (WISCI) v2 Upper extremity impairment evaluated using the grip strength with digital dynamometry, pinch strength (key pinch and tip-to-tip pinch), and the Partial Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) v2. All core outcome assessments will be performed at the baseline, 3-, and 6-month visits except for the PROMs, SCIM v3, key pinch and tip-to-tip pinch, which will be assessed only at the 3- and 6-month visits. The optional outcome assessment is the multiparametric quantitative spinal cord magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) which will be performed at baseline, 3-, and 6-month visits if it is done at the surgeon's discretion. The goal of this study is to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients with incomplete tetraplegia without spinal instability to capture the aspects of neurologic impairment that may not be well represented in the ISNCSCI examination.

Official Title
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IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis

Conditions
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Cervical Spinal Cord Injury

Intervention / Treatment
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* Procedure: Nonsurgical treatment
* Procedure: Surgical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years, inclusive Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 48 hours post injury Cervical neurological level of injury (C2-C8) MRI, using any imaging protocols (conventional, multiparametric, or quantitative), taken according to standard of care Presence of spinal cord compression on the MRI Absence of biomechanical instability to the extent that would mandate stabilization surgery by the treating surgeon Ability to provide informed consent according to the IRB/EC defined and approved procedures Exclusion Criteria: Nontraumatic SCI Concomitant traumatic brain injury or polytrauma that could preclude accurate or reliable assessments of the outcome assessments Uncontrolled severe systemic diseases, preexisting neurological, musculoskeletal, or general medical conditions which could preclude accurate assessments or FUs Individuals unable to undergo MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Nonsurgical treatment|Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest|
|Procedure: Surgical treatment|Anterior discectomy and instrumented fusion (single level), Anterior discectomy and instrumented fusion (multi-level), Posterior decompression-laminectomy, Posterior decompression-laminoplasty, Posterior decompression and instrumented fusion, Combined anterior and posterior decompression and instrumented fusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of the core outcome assessments successfully completed at each visit | For baseline and each FU visit, the completion status of each core outcome assessment | up to 6 months | 
| Time required to complete the individual core outcome assessments | For baseline and each FU visit, the time required for completion for each core outcome assessment will be recorded (start time, end time, and duration in mins) | up to 6 months | 
| Total time required to complete all core outcome assessments at each visit | The time required for completion will be measured to the nearest 0.1 second by using a digital timer, and the timing should start at the start of giving instructions to the patients or explaining the tests to the patients (start time) and end when the final score of the test is obtained (end time). | up to 6 months | 
| Completion rate of individual core outcome assessments (and their scorings if applicable) | Completion rate of individual core outcome assessments at each visit. | up to 6 months | 
| Completion rate of the multiparametric quantitative spinal cord MRI/DTI | Completion rate of the multiparametric quantitative spinal cord MRI/DTI | up to 6 months | 
| FU visit compliance rate and reasons for non-compliance | Completion status of FU visits, recorded at 3- and 6-month visits | up to 6 months | 
| Patient accrual rate | Whether the patient drops out from the study, recorded at the time of dropout | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results from the core outcome assessment ISNCSCI | Motor and sensory scores (motor score 0-100, pin prick score 0-112), AIS Grades, Clinical syndrome (Central Cord/Brown-Sequard/Anterior Cord/Conus Medullaris/Cauda Equina/No clinical syndrome/Not assessed) | up to 6 months | 
| Results from the core outcome assessment SF-36 v2 | Eight scale scores (0-100): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue or vitality, and general health perceptions | up to 6 months | 
| Results from the core outcome assessment Neuropathic pain score | Score 0-100 | up to 6 months | 
| Results from the core outcome assessment SCIMv3 | Three subscales: Self-care (0-20), Respiration and Sphincter Management (0-40), Mobility (room and toilet, 0-40) | up to 6 months | 
| Results from the core outcome assessment WISCI v2 | Level of walking (score 0-20) | up to 6 months | 
| Results from the core outcome assessment Key pinch and tip-to-tip pinch | Pinch strength in kg | up to 6 months | 
| Results from the core outcome assessment GRASSP v2 | Eight subtest scores Strength (0-50), Palmar sensation (0-12), Prehension Ability (0-12), Prehension Performance (0-20) | up to 6 months |