Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486038
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-14
Brief Title:
Quatitative MRI of the Spinal Cord in Cervical Myelopathy Assessment of Microstuctural Damage for Outcome Improvement
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Quatitative MRI of the Spinal Cord in Cervical Myelopathy Assessment of Microstuctural Damage for Outcome Improvement
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QCEMY
Brief Summary:
The aim of this low interventional study is to detect microstructural degeneration prior to the presentation worsening or persistence following surgical or conservative treatment of cervical degenerative myelopathy signs and symptoms using quantitative imaging metrics and functional biometric analysis
The endpoints of the study are to collect and compare the clinical biometric neurophysiological and imaging data
The objectives of the study are
to implement and validate a novel quantitative Magnetic Resonance qMRI protocol clinically for the identification and quantification of microstructural spinal cord damage
to compare qMRI data to clinical and neuromotors and corresponding neurophysiological data
to create an integrated diagnostic tool for early diagnosis and disease monitoring of myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical biometric imaging and neurophysiological data in patients suitable for surgical or non-surgical treatment
Patient will undergo
MRI baseline - 1 month- 6 months
clinical data collection baseline- 1 month - 6 months
neuromotor assessment baseline - 1 month - 6 months
neurophysiological assessment baseline - 6 months
surgery if applicable Quantitative MRI of the spinal cord could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage and to avoid surgical treatment in those who do not require it Additionally quantitative MRI in combination with clinical data such as neuromotor tests could provide an important approach to assess the effectiveness of the therapeutical approach
The endpoints of the study are to collect and compare the clinical biometric neurophysiological and imaging data
The objectives of the study are
to implement and validate a novel quantitative Magnetic Resonance qMRI protocol clinically for the identification and quantification of microstructural spinal cord damage
to compare qMRI data to clinical and neuromotors and corresponding neurophysiological data
to create an integrated diagnostic tool for early diagnosis and disease monitoring of myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical biometric imaging and neurophysiological data in patients suitable for surgical or non-surgical treatment
Patient will undergo
MRI baseline - 1 month- 6 months
clinical data collection baseline- 1 month - 6 months
neuromotor assessment baseline - 1 month - 6 months
neurophysiological assessment baseline - 6 months
surgery if applicable Quantitative MRI of the spinal cord could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage and to avoid surgical treatment in those who do not require it Additionally quantitative MRI in combination with clinical data such as neuromotor tests could provide an important approach to assess the effectiveness of the therapeutical approach
Detailed Description:
Rationale Degenerative cervical myelopathy DCM is a common chronic disorder and the most common cause of spinal cord dysfunction in adults potentially leading to severe functional impairment with high social costs More than 70 of people younger than 65 years have pathologic or radiologic evidence of cervical degenerative disease Symptoms of cervical compression develop in about 25 of these people Consequently identifying optimal treatment strategies and clinical care pathways for DCM has become a key public health priority DCM is caused by a progressive deterioration of osseocartilaginous components of the cervical spine leading to a narrowing of the spinal canal and compression of the long tracts and local segmental elements of the Spinal Cord SC DCM can lead to progressive disability and paralysis owing to chronic SC compression
In DCM an early diagnosis and monitoring are pivotal to avoid or constrain a neurological damage that may persist even after appropriate treatment is provided Diagnosis of DCM requires agreement between clinical and imaging findings MRI
Quantitative MRI of the SC could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage and to avoid surgical treatment in those who do not require it Additionally quantitative MRI in combination with clinical data such as neuromotor tests could provide an important approach to assess the effectiveness of the therapeutical approach
The plan with this project is to validate a newer clinically feasible quantitative MRI protocol to depict spinal cord microstructural changes determined by degenerative cervical spine disease that is highly frequent in the adult population Investigators are confident that to identify quantitative MRI-derived metrics that could objectively quantify spinal cord damage in degenerative cervical myelopathy and that could depict microstructural modifications even before neurological signs or signal alterations on morphological MRI sequences are evident This could be of pivotal importance for more precise indication to surgery and to prevent clinically significant damage that might not be recovered even after surgical treatment These data will be measured and validated by neurophysiological findings and compared to current scales and ad-hoc battery of neuromotor skill assessment tests
Clinical neurophysiological biometric and imaging follow-up will be performed to assess the predictive power of the identified metrics
This study aims to provide a new paradigm for improved depiction of the effects of degenerative cervical spondylosis that could become crucial for an individualized and timely therapeutic decision In DCM an early diagnosis is pivotal to avoid neurological damage that may persists even after appropriate treatment is provided More accurate integrated clinical imaging and functional evaluation is also advocated to improve the detection of subtle signs of sensory-motor disturbances and for increasing the inter-rater and intra-rater reliability of available scales In the proposed study for the first time the aim is to i integrate T1-based PSIR TI-scout and DTI metrics ii compare them to clinical neurophysiological and neuromotor skill performances and iii perform longitudinal pre- and post-operative ACDF evaluation
One important aspect to mention is that this study is performed for the first time given the availability of the new-generation polyetheretherketone PEEK and carbon fiber surgical hardware which allow the acquisition of the advanced quantitative MRI sequences without significant image distortion even when anterior cervical discectomy and fusion ACDF is performed
Through an artificial intelligence approach investigators also expect to develop a new objective scoring system that will include relevant items from MRI-derived metrics and clinical neurophysiological and neuromotor skills data Investigators foresee that the new scoring system could help clinician in identifying patients with the highest risk of progressing to irreversible neurological damage and that could overcome the limitations of the available clinical scales that include poor sensitivity and modest inter-rater and intra-rater reliability with limited ability to detect subtle disease progression
Therefore the expectation is to identify more objective and sensitive metrics of spinal cord disease burden through the identification of sensitive objective and quantitative biomarkers of neurological damage in DCM
The results of this project will provide a new reliable system for identifying patients at risk of progressing to irreversible functional impairment leading to a patient-centered approach a cost-effective prevention of neurological deficits and a cost-effective avoidance of unnecessary surgical interventions
Objectives
This is a multi-disciplinary study with a focus on subjects affected by cervical spondylosis DCM determining several degrees of myelopathy from mild to severe The study is aimed at identifying an enhanced clinical radiological and neuromotor skills evaluation at presentation seeking to early identify and quantify the disease burden likely through the depiction and validation of new neuroradiological and functional metrics This is meant to also tailor and strengthen the indication for surgery in order to depict microstructural degeneration before signs and symptoms presentation or worsening since neurological damage may persist even after appropriate treatment has been provided Additionally findings from magnetic resonance in combination with neuromotor assessment could be beneficial for patient monitoring after surgery
Primary objective To implement and validate a novel qMRI protocol clinically for the identification and quantification of microstructural SC damage Secondary objective To compare and correlate clinical and neurophysiological data and detailed movement analysis overall mobility walking performance postural stability spasticity upper limb dexterity detailed movement analysis with qMRI-derived metrics
Tertiary objective To elaborate an integrated diagnostic innovative tool for early diagnosis and disease monitoring of myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical biometric and imaging qMRI data assessed at short 1 month and long-term 6 months follow-up and neurophysiological data at long-term 6 months follow-up in patients who underwent either surgical or non-surgical treatment
The following aims will be pursued to identify more objective and sensitive metrics of the disease burden and prevent the neurological damage from overcoming a clinical threshold
Primary endpoint Quantitative MRI metrics Secondary endpoint
To combine
qMRI data
Clinical data mJOA and Barthel Index
Neurophysiologic data Somatosensory evoked potential PESS and Motor evoked potential MEP
Neuromotor skill assessment upper and lower limb Tertiary endpoint Through an artificial intelligence approach above mentioned clinical biometric neurophysiological and imaging data assessed at short 1 month and long-term 6 months follow-up in patients who underwent either surgical or non-surgical treatment will be combined in order to obtain an enhanced integrated diagnostic powerful tool for early diagnosis and disease monitoring od myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage
STUDY POPULATION The propose is a multicentric prospective longitudinal study classified as low interventional enrolling 100 adult subjects with a single-level degenerative spondylosis of the sub-axial cervical spine C3-C7 as diagnosed on a combination of symptoms signs and conventional MRI findings
Patient will undergo
MRI baseline - 1 month- 6 months
clinical data collection baseline- 1 month - 6 months
neuromotor assessment baseline - 1 month - 6 months
neurophysiological assessment baseline - 6 months
surgery if applicable The therapeutical treatment would remain standard No additional imaging sessions will be added in relation to the standard diagnostic and monitoring protocol Diagnostic MRI will be integrated with advanced sequences which pose no harm for patients and only extend the diagnostic procedure of an interval between 10 and 15 minutes In addition to traditional practice patients will receive ad-hoc neuromotor assessment from physical therapists with advanced software for motion analysis
In DCM an early diagnosis and monitoring are pivotal to avoid or constrain a neurological damage that may persist even after appropriate treatment is provided Diagnosis of DCM requires agreement between clinical and imaging findings MRI
Quantitative MRI of the SC could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage and to avoid surgical treatment in those who do not require it Additionally quantitative MRI in combination with clinical data such as neuromotor tests could provide an important approach to assess the effectiveness of the therapeutical approach
The plan with this project is to validate a newer clinically feasible quantitative MRI protocol to depict spinal cord microstructural changes determined by degenerative cervical spine disease that is highly frequent in the adult population Investigators are confident that to identify quantitative MRI-derived metrics that could objectively quantify spinal cord damage in degenerative cervical myelopathy and that could depict microstructural modifications even before neurological signs or signal alterations on morphological MRI sequences are evident This could be of pivotal importance for more precise indication to surgery and to prevent clinically significant damage that might not be recovered even after surgical treatment These data will be measured and validated by neurophysiological findings and compared to current scales and ad-hoc battery of neuromotor skill assessment tests
Clinical neurophysiological biometric and imaging follow-up will be performed to assess the predictive power of the identified metrics
This study aims to provide a new paradigm for improved depiction of the effects of degenerative cervical spondylosis that could become crucial for an individualized and timely therapeutic decision In DCM an early diagnosis is pivotal to avoid neurological damage that may persists even after appropriate treatment is provided More accurate integrated clinical imaging and functional evaluation is also advocated to improve the detection of subtle signs of sensory-motor disturbances and for increasing the inter-rater and intra-rater reliability of available scales In the proposed study for the first time the aim is to i integrate T1-based PSIR TI-scout and DTI metrics ii compare them to clinical neurophysiological and neuromotor skill performances and iii perform longitudinal pre- and post-operative ACDF evaluation
One important aspect to mention is that this study is performed for the first time given the availability of the new-generation polyetheretherketone PEEK and carbon fiber surgical hardware which allow the acquisition of the advanced quantitative MRI sequences without significant image distortion even when anterior cervical discectomy and fusion ACDF is performed
Through an artificial intelligence approach investigators also expect to develop a new objective scoring system that will include relevant items from MRI-derived metrics and clinical neurophysiological and neuromotor skills data Investigators foresee that the new scoring system could help clinician in identifying patients with the highest risk of progressing to irreversible neurological damage and that could overcome the limitations of the available clinical scales that include poor sensitivity and modest inter-rater and intra-rater reliability with limited ability to detect subtle disease progression
Therefore the expectation is to identify more objective and sensitive metrics of spinal cord disease burden through the identification of sensitive objective and quantitative biomarkers of neurological damage in DCM
The results of this project will provide a new reliable system for identifying patients at risk of progressing to irreversible functional impairment leading to a patient-centered approach a cost-effective prevention of neurological deficits and a cost-effective avoidance of unnecessary surgical interventions
Objectives
This is a multi-disciplinary study with a focus on subjects affected by cervical spondylosis DCM determining several degrees of myelopathy from mild to severe The study is aimed at identifying an enhanced clinical radiological and neuromotor skills evaluation at presentation seeking to early identify and quantify the disease burden likely through the depiction and validation of new neuroradiological and functional metrics This is meant to also tailor and strengthen the indication for surgery in order to depict microstructural degeneration before signs and symptoms presentation or worsening since neurological damage may persist even after appropriate treatment has been provided Additionally findings from magnetic resonance in combination with neuromotor assessment could be beneficial for patient monitoring after surgery
Primary objective To implement and validate a novel qMRI protocol clinically for the identification and quantification of microstructural SC damage Secondary objective To compare and correlate clinical and neurophysiological data and detailed movement analysis overall mobility walking performance postural stability spasticity upper limb dexterity detailed movement analysis with qMRI-derived metrics
Tertiary objective To elaborate an integrated diagnostic innovative tool for early diagnosis and disease monitoring of myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical biometric and imaging qMRI data assessed at short 1 month and long-term 6 months follow-up and neurophysiological data at long-term 6 months follow-up in patients who underwent either surgical or non-surgical treatment
The following aims will be pursued to identify more objective and sensitive metrics of the disease burden and prevent the neurological damage from overcoming a clinical threshold
Primary endpoint Quantitative MRI metrics Secondary endpoint
To combine
qMRI data
Clinical data mJOA and Barthel Index
Neurophysiologic data Somatosensory evoked potential PESS and Motor evoked potential MEP
Neuromotor skill assessment upper and lower limb Tertiary endpoint Through an artificial intelligence approach above mentioned clinical biometric neurophysiological and imaging data assessed at short 1 month and long-term 6 months follow-up in patients who underwent either surgical or non-surgical treatment will be combined in order to obtain an enhanced integrated diagnostic powerful tool for early diagnosis and disease monitoring od myelopathy and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage
STUDY POPULATION The propose is a multicentric prospective longitudinal study classified as low interventional enrolling 100 adult subjects with a single-level degenerative spondylosis of the sub-axial cervical spine C3-C7 as diagnosed on a combination of symptoms signs and conventional MRI findings
Patient will undergo
MRI baseline - 1 month- 6 months
clinical data collection baseline- 1 month - 6 months
neuromotor assessment baseline - 1 month - 6 months
neurophysiological assessment baseline - 6 months
surgery if applicable The therapeutical treatment would remain standard No additional imaging sessions will be added in relation to the standard diagnostic and monitoring protocol Diagnostic MRI will be integrated with advanced sequences which pose no harm for patients and only extend the diagnostic procedure of an interval between 10 and 15 minutes In addition to traditional practice patients will receive ad-hoc neuromotor assessment from physical therapists with advanced software for motion analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None