Cervical Spinal Cord Injury Clinical Trial
Official title:
IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
NCT number | NCT05653206 |
Other study ID # | IN-TWIN |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 11, 2023 |
Est. completion date | May 1, 2025 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo | São Paulo | |
Canada | St. Michael's Hospital | Toronto | |
Canada | Toronto Western Hospital University Health Network | Toronto | |
Canada | Vancouver Spine Research Program, Blusson Spinal Cord Centre | Vancouver | |
Germany | BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau | Murnau Am Staffelsee | |
India | Indian Spinal Injuries Centre | New Delhi | |
Portugal | Orthopaedics, Centro Hospitalar Universitário do Porto | Porto | |
United States | UMD STC Neurosurgery Clinic | Baltimore | Maryland |
United States | Medical college of Winsconsine, Neurosurgery | Milwaukee | Wisconsin |
United States | San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
AO Foundation, AO Spine |
United States, Brazil, Canada, Germany, India, Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Completion rate of the multiparametric quantitative spinal cord MRI/DTI | Completion rate of the multiparametric quantitative spinal cord MRI/DTI | up to 6 months | |
Primary | 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 | |
Primary | Patient accrual rate | Whether the patient drops out from the study, recorded at the time of dropout | up to 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Results from the core outcome assessment Neuropathic pain score | Score 0-100 | up to 6 months | |
Secondary | 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 | |
Secondary | Results from the core outcome assessment WISCI v2 | Level of walking (score 0-20) | up to 6 months | |
Secondary | Results from the core outcome assessment Key pinch and tip-to-tip pinch | Pinch strength in kg | up to 6 months | |
Secondary | 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 |
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