Clinical trial NCT05653206: Incomplete Cervical SCI Without Instability
Official title: IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Spinal Cord Injury
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with traumatic incomplete cervical SCI without instability

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The proportion of the core outcome assessments successfully completed at each visit
timeFrame: up to 6 months
measure: Time required to complete the individual core outcome assessments
timeFrame: up to 6 months
measure: Total time required to complete all core outcome assessments at each visit
timeFrame: up to 6 months
measure: Completion rate of individual core outcome assessments (and their scorings if applicable)
timeFrame: up to 6 months
measure: Completion rate of the multiparametric quantitative spinal cord MRI/DTI
timeFrame: up to 6 months
measure: FU visit compliance rate and reasons for non-compliance
timeFrame: up to 6 months
measure: Patient accrual rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Results from the core outcome assessment ISNCSCI
timeFrame: up to 6 months
measure: Results from the core outcome assessment SF-36 v2
timeFrame: up to 6 months
measure: Results from the core outcome assessment Neuropathic pain score
timeFrame: up to 6 months
measure: Results from the core outcome assessment SCIMv3
timeFrame: up to 6 months
measure: Results from the core outcome assessment WISCI v2
timeFrame: up to 6 months
measure: Results from the core outcome assessment Key pinch and tip-to-tip pinch
timeFrame: up to 6 months
measure: Results from the core outcome assessment GRASSP v2
timeFrame: up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Baltimore
country: United States
facility: UMD STC Neurosurgery Clinic
state: Maryland
city: Milwaukee
country: United States
facility: Medical college of Winsconsine, Neurosurgery
state: Wisconsin
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Toronto
country: Canada
facility: Toronto Western Hospital University Health Network
city: Vancouver
country: Canada
facility: Vancouver Spine Research Program, Blusson Spinal Cord Centre
city: Murnau Am Staffelsee
country: Germany
facility: BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau
city: New Delhi
country: India
facility: Indian Spinal Injuries Centre
city: Porto
country: Portugal
facility: Orthopaedics, Centro Hospitalar Universitário do Porto
Study officials:
affiliation: Unity Health Toronto
name: Jefferson Wilson
role: PRINCIPAL_INVESTIGATOR
References: