Incomplete Cervical SCI Without Instability

AO Foundation, AO Spine

Status: Enrolling

Conditions: Cervical Spinal Cord Injury

Treatments: Procedure: Surgical treatment; Procedure: Nonsurgical treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05653206

IN-TWIN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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