Observational study of incomplete cervical spinal cord injury without instability
IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
This study is looking to see how well different tests can measure recovery in adults with certain types of cervical spinal cord injuries over a few months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | AO Foundation, AO Spine Academic / other |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Trial ID | NCT05653206 on ClinicalTrials.gov |
What this trial studies
This multicenter, international observational study aims to enroll 50 adult patients with acute traumatic cervical spinal cord injury (SCI) classified as ISNCSCI AIS Grade D or with sensory deficits only. Participants will undergo a series of core and optional outcome assessments to evaluate neurological impairment and functional outcomes over a follow-up period of 3 and 6 months. Data collected will include demographic information, injury details, treatment specifics, and various assessments of neurological status, gait, balance, and upper extremity function. The study seeks to inform the feasibility of these assessments in capturing the complexities of cervical SCI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with acute traumatic cervical SCI and specific neurological classifications.
Not a fit: Patients with nontraumatic SCI or those with severe systemic diseases or conditions that could affect assessment accuracy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of neurological impairments in cervical SCI patients and improve outcome assessments.
How similar studies have performed: While similar observational studies have been conducted, this specific approach to assessing incomplete cervical SCI without instability is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 9 other locations
- San Francisco General Hospital — San Francisco, California, United States (Recruiting)
- UMD STC Neurosurgery Clinic — Baltimore, Maryland, United States (Recruiting)
- Medical college of Winsconsine, Neurosurgery — Milwaukee, Wisconsin, United States (Recruiting)
- Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo — São Paulo, Brazil (Recruiting)
- St. Michael's Hospital — Toronto, Canada (Recruiting)
- Toronto Western Hospital University Health Network — Toronto, Canada (Recruiting)
- Vancouver Spine Research Program, Blusson Spinal Cord Centre — Vancouver, Canada (Recruiting)
- BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau — Murnau Am Staffelsee, Germany (Recruiting)
- Indian Spinal Injuries Centre — New Delhi, India (Recruiting)
- Orthopaedics, Centro Hospitalar Universitário do Porto — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Jefferson Wilson — Unity Health Toronto
- Study coordinator: Alix Frischknecht
- Email: alix.frischknecht@aofoundation.org
- Phone: +41 79 606 41 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.