IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Total time required to complete all core outcome assessments at each visit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, inclusive
- •Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 92 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
排除标准
- •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
结局指标
主要结局
Total time required to complete all core outcome assessments at each visit
时间窗: up to 6 months
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).
The proportion of the core outcome assessments successfully completed at each visit
时间窗: up to 6 months
For baseline and each FU visit, the completion status of each core outcome assessment
Patient accrual rate
时间窗: up to 6 months
Whether the patient drops out from the study, recorded at the time of dropout
Time required to complete the individual core outcome assessments
时间窗: up to 6 months
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)
Completion rate of individual core outcome assessments (and their scorings if applicable)
时间窗: up to 6 months
Completion rate of individual core outcome assessments at each visit.
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
时间窗: up to 6 months
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
FU visit compliance rate and reasons for non-compliance
时间窗: up to 6 months
Completion status of FU visits, recorded at 3- and 6-month visits
次要结局
- Results from the core outcome assessment GRASSP v2(up to 6 months)
- Results from the core outcome assessment ISNCSCI(up to 6 months)
- Results from the core outcome assessment Neuropathic pain score(up to 6 months)
- Results from the core outcome assessment Key pinch and tip-to-tip pinch(up to 6 months)
- Results from the core outcome assessment SCIMv3(up to 6 months)
- Results from the core outcome assessment SF-36 v2(up to 6 months)
- Results from the core outcome assessment WISCI v2(up to 6 months)