Degenerative Cervical Spinal MyelopathyNOLOSTNCT06094166
Quantitative MR Parameters in Non-myelopathic Degenerative Cervical Spinal Cord Compression: a Longitudinal Study.
An observational study of Degenerative Cervical Spinal Myelopathy and Cervical Spinal Cord Compression, run by Masaryk University at 1 site in Czechia.
Trial summary
Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Cervical Spinal Myelopathy, Cervical Spinal Cord Compression
- What is being tested?
- MRI
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2022to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)
Who may be able to join
- Subject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.
Who cannot join
- A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
- Pregnancy
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Masaryk University, Brno
Brno
Tomas Horak, MD, +420724273734, tomas.horak@fnbrno.cz
About this study
Official title: Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
Read the detailed description
The study uses semi-automated detection of anatomical metrics (morphometric parameters) and DCC with Spinal Cord Toolbox (SCT). This method have been proven more reliable than expert's manual rating, the introduction of the automated method will be utilized in the future multi-centre and longitudinal studies. Routine anatomical morphometric parameters such as compressive ratio (CR) and cross-sectional area (CSA) will be acquired along with microstructural and metabolic metrics obtained with validated dMRI and MRS methods, remote cervical cord atrophy from voxel-based MRI volumetry, T2* white matter/gray matter (WM/GM) signal-intensity ratio, and also metrics obtained with novel Intravoxel Incoherent Motion (IVIM) method will predict progression of NMDCC into symptomatic DCM. "Natural course" (i.e., speed of progression) of the severity of DCC assessed with anatomical and advanced MRI/MRS metrics is not known but may play a role in the progression from NMDCC to symptomatic DCM. Aims of this project are: To determine independent predictors of unfavourable outcome - progression into symptomatic degenerative cervical myelopathy (DCM) - among quantitative MRI parameters and compare them with already defined clinical and electrophysiological predictors. To evaluate the "natural course" of MRI descriptors of compression and its severity, and the correlation between progression and development of symptomatic DCM. To implement automated detection of cervical cord compression using Spinal Cord Toolbox based on automatically computed morphometric parameters.
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Quantitative imaging MR parameters
| Study group | Role | What they receive |
|---|---|---|
| NMDCC | non-myelopathic cervical spinal cord compression Receives: Diagnostic Test: MRI | |
| healthy controls | subjects with no MR signs of cervical spinal cord compression Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical MRI metrics
compressive ratio (CR)
Measured: 45 minutes
Anatomical MRI metrics
cross-sectional area (CSA)
Measured: 45 minutes
dMRI: signs of microstructural myelopathy
fractional anisotropy
Measured: 45 minutes
MRS: signs of metabolic myelopathy (above the level of compression)
Myo-ins/NAA ratio
Measured: 45 minutes
Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)
remote cervical cord atrophy
Measured: 45 minutes
Secondary outcomes (1)
IVIM and T2*WM/GM signal-intensity ratio
Intravoxel incoherent motion detection
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical Spinal MyelopathyStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Tomáš Horák, Masaryk University
- Investigators
- Josef Bednarik, Prof. MD., Principal investigator, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094166
- Sponsor's protocol ID
- 66138
- Acronym
- NOLOST
- Status last verified
- Oct 2023
- First submitted
- 12 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT06094166
- Acronym / sponsor ID
- NOLOST / 66138
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study
Detailed description
The study uses semi-automated detection of anatomical metrics (morphometric parameters) and DCC with Spinal Cord Toolbox (SCT). This method have been proven more reliable than expert's manual rating, the introduction of the automated method will be utilized in the future multi-centre and longitudinal studies. Routine anatomical morphometric parameters such as compressive ratio (CR) and cross-sectional area (CSA) will be acquired along with microstructural and metabolic metrics obtained with validated dMRI and MRS methods, remote cervical cord atrophy from voxel-based MRI volumetry, T2* white matter/gray matter (WM/GM) signal-intensity ratio, and also metrics obtained with novel Intravoxel Incoherent Motion (IVIM) method will predict progression of NMDCC into symptomatic DCM. "Natural course" (i.e., speed of progression) of the severity of DCC assessed with anatomical and advanced MRI/MRS metrics is not known but may play a role in the progression from NMDCC to symptomatic DCM. Aims of this project are: To determine independent predictors of unfavourable outcome - progression into symptomatic degenerative cervical myelopathy (DCM) - among quantitative MRI parameters and compare them with already defined clinical and electrophysiological predictors. To evaluate the "natural course" of MRI descriptors of compression and its severity, and the correlation between progression and development of symptomatic DCM. To implement automated detection of cervical cord compression using Spinal Cord Toolbox based on automatically computed morphometric parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMDCC | – | Diagnostic Test: MRInon-myelopathic cervical spinal cord compression |
| healthy controls | – | Diagnostic Test: MRIsubjects with no MR signs of cervical spinal cord compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)
Key inclusion criteria (1 listed)
- Subject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.
Key exclusion criteria (3 listed)
- A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
- Pregnancy
- Claustrophobia
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 |
|---|---|---|
| MRIQuantitative imaging MR parameters | Diagnostic test | NMDCC, healthy controls |
Primary outcome
Anatomical MRI metrics
Time frame: 45 minutes
compressive ratio (CR)
Anatomical MRI metrics
Time frame: 45 minutes
cross-sectional area (CSA)
dMRI: signs of microstructural myelopathy
Time frame: 45 minutes
fractional anisotropy
MRS: signs of metabolic myelopathy (above the level of compression)
Time frame: 45 minutes
Myo-ins/NAA ratio
Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)
Time frame: 45 minutes
remote cervical cord atrophy
1 secondary outcome
IVIM and T2*WM/GM signal-intensity ratio
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Josef Bednarik, Prof. MD. principal investigator
Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Cervical Spinal Myelopathy and Cervical Spinal Cord Compression, run by Masaryk University at 1 site in Czechia.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Horak, MD. PhD. (+420724273734, horak.tomas@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical MRI metrics (time frame: 45 minutes). The study lists 5 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 23 Oct 2023.