Cervical Spinal Cord InjuryNCT05653206
Incomplete Cervical SCI Without Instability
An observational study of Cervical Spinal Cord Injury, run by AO Foundation, AO Spine at 10 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Nonsurgical treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 11 Dec 2023to 18 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with traumatic incomplete cervical SCI without instability
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States3 sites
UMD STC Neurosurgery Clinic
Baltimore, Maryland, 21201
Medical college of Winsconsine, Neurosurgery
Milwaukee, Wisconsin, 53226
San Francisco General Hospital
San Francisco, California, 94143
Canada3 sites
St. Michael's Hospital
Toronto, M5B1W8
Toronto Western Hospital University Health Network
Toronto, M6S2W5
Vancouver Spine Research Program, Blusson Spinal Cord Centre
Vancouver, V5Z 1M9
Brazil1 site
Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo
São Paulo, 05403-010
Germany1 site
BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau
Murnau am Staffelsee, 82418
Portugal1 site
Orthopaedics, Centro Hospitalar Universitário do Porto
Porto, 4099-001
About this study
Official title: IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
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.
Read the 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.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Nonsurgical treatment, Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical treatmentProcedure or surgery
Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest
Surgical treatmentProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
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)
Measured: up to 6 months
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).
Measured: up to 6 months
Completion rate of individual core outcome assessments (and their scorings if applicable)
Completion rate of individual core outcome assessments at each visit.
Measured: up to 6 months
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Measured: up to 6 months
FU visit compliance rate and reasons for non-compliance
Completion status of FU visits, recorded at 3- and 6-month visits
Measured: up to 6 months
Patient accrual rate
Whether the patient drops out from the study, recorded at the time of dropout
Measured: up to 6 months
Secondary outcomes (7)
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)
Measured: up to 6 months
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
Measured: up to 6 months
Results from the core outcome assessment Neuropathic pain score
Score 0-100
Measured: up to 6 months
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)
Measured: up to 6 months
Results from the core outcome assessment WISCI v2
Level of walking (score 0-20)
Measured: up to 6 months
Results from the core outcome assessment Key pinch and tip-to-tip pinch
Pinch strength in kg
Measured: up to 6 months
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)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start11 Dec 2023
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jefferson Wilson, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653206
- Sponsor's protocol ID
- IN-TWIN
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
- ClinicalTrials.gov ID
- NCT05653206
- Acronym / sponsor ID
- IN-TWIN
- Conditions
- Cervical Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic incomplete cervical SCI without instability
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonsurgical treatmentCervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest | Procedure or surgery | – |
| Surgical treatmentAnterior 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 | Procedure or surgery | – |
Primary outcome
The proportion of the core outcome assessments successfully completed at each visit
Time frame: up to 6 months
For baseline and each FU visit, the completion status of each core outcome assessment
Time required to complete the individual core outcome assessments
Time frame: up to 6 months
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)
Total time required to complete all core outcome assessments at each visit
Time frame: up to 6 months
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).
Completion rate of individual core outcome assessments (and their scorings if applicable)
Time frame: up to 6 months
Completion rate of individual core outcome assessments at each visit.
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Time frame: up to 6 months
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
FU visit compliance rate and reasons for non-compliance
Time frame: up to 6 months
Completion status of FU visits, recorded at 3- and 6-month visits
Patient accrual rate
Time frame: up to 6 months
Whether the patient drops out from the study, recorded at the time of dropout
7 secondary outcomes
Results from the core outcome assessment ISNCSCI
Time frame: up to 6 months
Results from the core outcome assessment SF-36 v2
Time frame: up to 6 months
Results from the core outcome assessment Neuropathic pain score
Time frame: up to 6 months
Results from the core outcome assessment SCIMv3
Time frame: up to 6 months
Results from the core outcome assessment WISCI v2
Time frame: up to 6 months
Results from the core outcome assessment Key pinch and tip-to-tip pinch
Time frame: up to 6 months
Results from the core outcome assessment GRASSP v2
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jefferson Wilson principal investigator
Unity Health Toronto
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spinal Cord Injury, run by AO Foundation, AO Spine at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Brazil, Germany, India and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of the core outcome assessments successfully completed at each visit (time frame: up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.