Incomplete Cervical SCI Without Instability (NCT05653206) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Incomplete Cervical SCI Without Instability
United States, Brazil, Canada50 participantsStarted 2023-12-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of the core outcome assessments successfully completed at each visit
Timeframe: up to 6 months
2
Time required to complete the individual core outcome assessments
Timeframe: up to 6 months
3
Total time required to complete all core outcome assessments at each visit
Timeframe: up to 6 months
4
Completion rate of individual core outcome assessments (and their scorings if applicable)
Timeframe: up to 6 months
5
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Timeframe: up to 6 months
6
FU visit compliance rate and reasons for non-compliance