Incomplete Cervical SCI Without Instability

Cervical Spinal Cord Injury Clinical Trial

Official title:

IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653206
• Other study ID #: IN-TWIN
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2024
• Source: AO Foundation, AO Spine
• Contact: Alix Frischknecht
• Phone: +41 79 606 41 48
• Email: alix.frischknecht[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Procedure:
• Nonsurgical treatment
Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest
• Surgical treatment
Anterior discectomy and instrumented fusion (single level), Anterior discectomy and instrumented fusion (multi-level), Posterior decompression-laminectomy, Posterior decompression-laminoplasty, Posterior decompression and instrumented fusion, Combined anterior and posterior decompression and instrumented fusion

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo	São Paulo
Canada	St. Michael's Hospital	Toronto
Canada	Toronto Western Hospital University Health Network	Toronto
Canada	Vancouver Spine Research Program, Blusson Spinal Cord Centre	Vancouver
Germany	BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau	Murnau Am Staffelsee
India	Indian Spinal Injuries Centre	New Delhi
Portugal	Orthopaedics, Centro Hospitalar Universitário do Porto	Porto
United States	UMD STC Neurosurgery Clinic	Baltimore	Maryland
United States	Medical college of Winsconsine, Neurosurgery	Milwaukee	Wisconsin
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AO Foundation, AO Spine

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Germany,  India,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of the core outcome assessments successfully completed at each visit	For baseline and each FU visit, the completion status of each core outcome assessment	up to 6 months
Primary	Time required to complete the individual core outcome assessments	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)	up to 6 months
Primary	Total time required to complete all core outcome assessments at each visit	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).	up to 6 months
Primary	Completion rate of individual core outcome assessments (and their scorings if applicable)	Completion rate of individual core outcome assessments at each visit.	up to 6 months
Primary	Completion rate of the multiparametric quantitative spinal cord MRI/DTI	Completion rate of the multiparametric quantitative spinal cord MRI/DTI	up to 6 months
Primary	FU visit compliance rate and reasons for non-compliance	Completion status of FU visits, recorded at 3- and 6-month visits	up to 6 months
Primary	Patient accrual rate	Whether the patient drops out from the study, recorded at the time of dropout	up to 6 months
Secondary	Results from the core outcome assessment ISNCSCI	Motor and sensory scores (motor score 0-100, pin prick score 0-112), AIS Grades, Clinical syndrome (Central Cord/Brown-Sequard/Anterior Cord/Conus Medullaris/Cauda Equina/No clinical syndrome/Not assessed)	up to 6 months
Secondary	Results from the core outcome assessment SF-36 v2	Eight scale scores (0-100): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue or vitality, and general health perceptions	up to 6 months
Secondary	Results from the core outcome assessment Neuropathic pain score	Score 0-100	up to 6 months
Secondary	Results from the core outcome assessment SCIMv3	Three subscales: Self-care (0-20), Respiration and Sphincter Management (0-40), Mobility (room and toilet, 0-40)	up to 6 months
Secondary	Results from the core outcome assessment WISCI v2	Level of walking (score 0-20)	up to 6 months
Secondary	Results from the core outcome assessment Key pinch and tip-to-tip pinch	Pinch strength in kg	up to 6 months
Secondary	Results from the core outcome assessment GRASSP v2	Eight subtest scores Strength (0-50), Palmar sensation (0-12), Prehension Ability (0-12), Prehension Performance (0-20)	up to 6 months