Cervical Spondylosis With MyelopathyNCT01868958
DTI of the Brain and Cervical Spine: Evaluation in Normal Subjects and Patients With Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylosis With Myelopathy, run by Emory University at 1 site in United States.
Trial summary
More than half of the middle-aged population has radiologic evidence of cervical spondylosis (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylosis With Myelopathy
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2015
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at the Emory Orthopaedics \& Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
Who may be able to join
- 20 patients will be selected by an experienced team of orthopedic specialist from the Emory Orthopaedics \& Spine Center and will include patients suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
- 20 controls : Aged matched to the patient group. No history of CSM.
Who cannot join
- Any history of significant trauma implicating the brain or cervical spine, including prior motor vehicle collision and history of prior brain, neck or cervical spine surgery.
- Any history of neurological disease
- Dental braces or similar orthodontic devices.
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Systems Imaging (CSI), Emory University
Atlanta, Georgia, 30329
About this study
Official title: Diffusion Tensor Imaging of the Brain and Cervical Spine: Evaluation of Reproducibility in Normal Subjects and Diagnostic Utility in Patients With Cervical Spondylotic Myelopathy
More than half of the middle-aged population has radiologic evidence of cervical spondylosis (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the hypothesis that diffusion tensor imaging can provide prognostic information on the integrity of the spine in these patients which is unavailable from conventional MRI images
Read the detailed description
More than half of the middle-aged population has radiologic evidence of cervical spondylosis and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. Although many operations are performed for conditions related to CSM, no consensus exists regarding the timing of the surgical intervention or how to select among the available surgical options for a given patient. Many factors have been implicated in the propensity for CSM to develop including advanced age, disability at presentation, cord diameter, cord area, altered cord signal on MRI (T2- and T1- weighted images), increased cervical spinal mobility and a congenitally narrow spinal canal. The same factors may also determine the response to surgery, either positively (increased cervical mobility) or negatively (advanced age, congenitally narrow spinal canal). The potential complications of surgical procedures are noteworthy. Although incapacitating adverse effects are uncommon, their occurrence in a disease process with a potentially benign course is of undoubted gravity. Finally, it should be noted that the radiologic criteria of cervical root or cord compression on MRI are subjective and it is uncertain that they correlate with the clinical symptoms.
Diffusion tensor imaging (DTI) is sensitive to the motion of water and is considered to be a marker for axonal integrity in the brain. There has been much interest in applying the technique to the spine and in particular to the evaluation of patients with CSM. In the brain DTI is performed using a single shot echo planar imaging (SS-EPI) sequence which acquires all of the data for a single slice following the application of a single excitation pulse and diffusion gradients. While very efficient in terms of data collections there are several problems with SS-EPI, notably that 1) It is best suited to the acquisition of relatively small imaging matrices, resulting in either low spatial resolution or the use of additional techniques to reduce the field of view (FOV). Increasing the number of echoes acquired to increase the resolution does not produce an increase in the acquired resolution since the decay of the signal during the longer echo train results in increased blurring of the image. 2) The images are distorted by susceptibility gradients in areas close to the interfaces between tissue and bone or osseous structures. These factors have made applying DTI to clinical studies of the spine problematic. Specifically:-
- The small size of the spinal cord means that high spatial resolution is required.
- The susceptibility effects from the surrounding osseous structure result in image distortion.
- The motion of the cord during the cardiac cycle leads to artifacts.
Readout segmented EPI (RESOLVE or RS-EPI) sequence has been shown to be capable of obtaining images with higher spatial resolution and reduced distortion in the brain. We have recently demonstrated that the RESOLVE sequence can also be used to obtain high quality DTI images of the cervical spine of volunteers (see figure 1) and can provide clinically useful information in subjects with metastases in the spine. The RESOLVE sequence breaks the data collection into several segments, resulting in reduced distortion and the potential to obtain images with higher resolution, but at the cost of either increased scan time or a reduced number of directions for the diffusion gradients (i.e. reduced signal to noise ratio (SNR)). The RESOLVE sequence also incorporates real-time assessment of the data, enabling data corrupted by motion to be rejected and then reacquired. We now wish to optimize, and assess the clinical utility of, the RESOLVE sequence in patients with CSM by applying it to a group of CSM patients and a group of aged matched control subjects. The raw diffusion images are post-processed to yield parametric images which characterize the diffusivity (mean, longitudinal and radial) and anisotropy (directional dependence) of the diffusion. The anisotropy of the diffusion data is typically quantified using the fractional anisotropy (FA) index, however, we have recently shown that two other quantities, the mode and ellipsoidal area ratio (EAR) of the diffusion tensor, provide useful supplementary information and we propose to use all three parameters when analyzing the anisotropy of the diffusion data from this study.
Using the RESOLVE sequence address these first two of the "bullet" points listed above and we found that in some subjects high quality DTI images of the spine can be obtained without the use of cardiac gating, however, for a robust clinical sequence we, and other groups, have found cardiac gating to be essential. Another issue to consider for DTI studies of the spine is the orientation of the scan. Sagittal images provide coverage of the whole spine with relatively few slices, which is particularly beneficial when cardiac gating is employed. Axial slices have the advantage that the changes in the configuration of the spine in the caudal-cranial direction are relatively slow, meaning that thicker slices can be used without a significant loss of information. However, a relatively large number of slices are still required to cover the entire C-spine resulting in a lengthy measurement time when cardiac gating is used.
Objectives The investigators wish to try and answer the following questions for the C-spine:-
- What are the diffusion characteristic of the normal C-spine (spatial variation and age dependence)?
- How do the RESOLVE and SS-EPI images of the spine compare in terms of image quality?
- What is the effect of changing the number of segments for the RESOLVE sequence?
- When comparing SS-EPI and RESOLVE are there statistically significant differences in the derived values of anisotropy or diffusivity?
- Are the diffusion characteristics of the C-spine of subjects with CSM significantly different from those of aged matched controls?
- Can DTI of the spine be used to derive diagnostic information, either in terms of prognostic information for individual CSM patients or the identification of sub-groups of CSM patients? For the brain the question we would be addressing are:-
- When comparing SS-EPI and RESOLVE are there statistically significant differences in the derived values of anisotropy or diffusivity? 2) Is there a statistically significant difference in the volume of the fiber tracts derived using the two sequences or between the two groups? 3) Is the diffusion data from the brains of patients with CSM significantly different from that of the controls?
- Conditions
- Cervical Spondylosis With Myelopathy
- Keywords
- Magnetic resonance imaging (MRI), Diffusion tensor imaging, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CSM subjects | Subjects with clinical indications of cervical spondylotic myelopathy (CSM). | |
| Control group | Aged matched to the CSM group but with no signs of CSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion properties of the spinal cord
Two parameters characterizing the diffusion of water in the spinal cord will be studied.
- The fractional anisotropy reflects the orientational motion of water and the average value will be assessed over the length of the cervical spine for both the control and patient groups. This quantity has no units.
- The trace of the diffusion tensor. This measures the mean diffusivity of the water in the spinal cord and is measured in m^2/sec.
Measured: The diffusion properties are measured in a single imaging session lasting approximately 50 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylosis With MyelopathyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Principal investigator, Richard Jones, Emory University
- Investigators
- Richard A Jones, PhD, Principal investigator, Department of Radiology, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868958
- Sponsor's protocol ID
- IRB00058267
- Status last verified
- Jul 2015
- First submitted
- 13 May 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes LL, Jones RA, Palasis S, Aguilera D, Porter DA. Drop metastases to the pediatric spine revealed with diffusion-weighted MR imaging. Pediatr Radiol. 2012 Aug;42(8):1009-13. doi: 10.1007/s00247-011-2295-9. Epub 2011 Nov 4.
PubMed 22052343
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Tensor Imaging of the Brain and Cervical Spine: Evaluation of Reproducibility in Normal Subjects and Diagnostic Utility in Patients With Cervical Spondylotic Myelopathy
- ClinicalTrials.gov ID
- NCT01868958
- Acronym / sponsor ID
- IRB00058267
- Conditions
- Cervical Spondylosis With Myelopathy
- Keywords
- Magnetic resonance imaging (MRI), Diffusion tensor imaging, Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Jun 2013 (estimated)
- 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.
More than half of the middle-aged population has radiologic evidence of cervical spondylosis (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the hypothesis that diffusion tensor imaging can provide prognostic information on the integrity of the spine in these patients which is unavailable from conventional MRI images
Detailed description
More than half of the middle-aged population has radiologic evidence of cervical spondylosis and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. Although many operations are performed for conditions related to CSM, no consensus exists regarding the timing of the surgical intervention or how to select among the available surgical options for a given patient. Many factors have been implicated in the propensity for CSM to develop including advanced age, disability at presentation, cord diameter, cord area, altered cord signal on MRI (T2- and T1- weighted images), increased cervical spinal mobility and a congenitally narrow spinal canal. The same factors may also determine the response to surgery, either positively (increased cervical mobility) or negatively (advanced age, congenitally narrow spinal canal). The potential complications of surgical procedures are noteworthy. Although incapacitating adverse effects are uncommon, their occurrence in a disease process with a potentially benign course is of undoubted gravity. Finally, it should be noted that the radiologic criteria of cervical root or cord compression on MRI are subjective and it is uncertain that they correlate with the clinical symptoms.
Diffusion tensor imaging (DTI) is sensitive to the motion of water and is considered to be a marker for axonal integrity in the brain. There has been much interest in applying the technique to the spine and in particular to the evaluation of patients with CSM. In the brain DTI is performed using a single shot echo planar imaging (SS-EPI) sequence which acquires all of the data for a single slice following the application of a single excitation pulse and diffusion gradients. While very efficient in terms of data collections there are several problems with SS-EPI, notably that 1) It is best suited to the acquisition of relatively small imaging matrices, resulting in either low spatial resolution or the use of additional techniques to reduce the field of view (FOV). Increasing the number of echoes acquired to increase the resolution does not produce an increase in the acquired resolution since the decay of the signal during the longer echo train results in increased blurring of the image. 2) The images are distorted by susceptibility gradients in areas close to the interfaces between tissue and bone or osseous structures. These factors have made applying DTI to clinical studies of the spine problematic. Specifically:-
- The small size of the spinal cord means that high spatial resolution is required.
- The susceptibility effects from the surrounding osseous structure result in image distortion.
- The motion of the cord during the cardiac cycle leads to artifacts.
Readout segmented EPI (RESOLVE or RS-EPI) sequence has been shown to be capable of obtaining images with higher spatial resolution and reduced distortion in the brain. We have recently demonstrated that the RESOLVE sequence can also be used to obtain high quality DTI images of the cervical spine of volunteers (see figure 1) and can provide clinically useful information in subjects with metastases in the spine. The RESOLVE sequence breaks the data collection into several segments, resulting in reduced distortion and the potential to obtain images with higher resolution, but at the cost of either increased scan time or a reduced number of directions for the diffusion gradients (i.e. reduced signal to noise ratio (SNR)). The RESOLVE sequence also incorporates real-time assessment of the data, enabling data corrupted by motion to be rejected and then reacquired. We now wish to optimize, and assess the clinical utility of, the RESOLVE sequence in patients with CSM by applying it to a group of CSM patients and a group of aged matched control subjects. The raw diffusion images are post-processed to yield parametric images which characterize the diffusivity (mean, longitudinal and radial) and anisotropy (directional dependence) of the diffusion. The anisotropy of the diffusion data is typically quantified using the fractional anisotropy (FA) index, however, we have recently shown that two other quantities, the mode and ellipsoidal area ratio (EAR) of the diffusion tensor, provide useful supplementary information and we propose to use all three parameters when analyzing the anisotropy of the diffusion data from this study.
Using the RESOLVE sequence address these first two of the "bullet" points listed above and we found that in some subjects high quality DTI images of the spine can be obtained without the use of cardiac gating, however, for a robust clinical sequence we, and other groups, have found cardiac gating to be essential. Another issue to consider for DTI studies of the spine is the orientation of the scan. Sagittal images provide coverage of the whole spine with relatively few slices, which is particularly beneficial when cardiac gating is employed. Axial slices have the advantage that the changes in the configuration of the spine in the caudal-cranial direction are relatively slow, meaning that thicker slices can be used without a significant loss of information. However, a relatively large number of slices are still required to cover the entire C-spine resulting in a lengthy measurement time when cardiac gating is used.
Objectives The investigators wish to try and answer the following questions for the C-spine:-
- What are the diffusion characteristic of the normal C-spine (spatial variation and age dependence)?
- How do the RESOLVE and SS-EPI images of the spine compare in terms of image quality?
- What is the effect of changing the number of segments for the RESOLVE sequence?
- When comparing SS-EPI and RESOLVE are there statistically significant differences in the derived values of anisotropy or diffusivity?
- Are the diffusion characteristics of the C-spine of subjects with CSM significantly different from those of aged matched controls?
- Can DTI of the spine be used to derive diagnostic information, either in terms of prognostic information for individual CSM patients or the identification of sub-groups of CSM patients? For the brain the question we would be addressing are:-
- When comparing SS-EPI and RESOLVE are there statistically significant differences in the derived values of anisotropy or diffusivity? 2) Is there a statistically significant difference in the volume of the fiber tracts derived using the two sequences or between the two groups? 3) Is the diffusion data from the brains of patients with CSM significantly different from that of the controls?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSM subjects | – | –Subjects with clinical indications of cervical spondylotic myelopathy (CSM). |
| Control group | – | –Aged matched to the CSM group but with no signs of CSM |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the Emory Orthopaedics \& Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
Key inclusion criteria (2 listed)
- 20 patients will be selected by an experienced team of orthopedic specialist from the Emory Orthopaedics \& Spine Center and will include patients suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with or without abnormal spinal cord signal intensity secondary to spondylosis.
- 20 controls : Aged matched to the patient group. No history of CSM.
Key exclusion criteria (4 listed)
- Any history of significant trauma implicating the brain or cervical spine, including prior motor vehicle collision and history of prior brain, neck or cervical spine surgery.
- Any history of neurological disease
- Dental braces or similar orthodontic devices.
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diffusion properties of the spinal cord
Time frame: The diffusion properties are measured in a single imaging session lasting approximately 50 minutes.
Two parameters characterizing the diffusion of water in the spinal cord will be studied. 1. The fractional anisotropy reflects the orientational motion of water and the average value will be assessed over the length of the cervical spine for both the control and patient groups. This quantity has no units. 2. The trace of the diffusion tensor. This measures the mean diffusivity of the water in the spinal cord and is measured in m^2/sec.
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 15 Jul 2015.
- Background: PubMed 22052343Hayes LL, Jones RA, Palasis S, Aguilera D, Porter DA. Drop metastases to the pediatric spine revealed with diffusion-weighted MR imaging. Pediatr Radiol. 2012 Aug;42(8):1009-13. doi: 10.1007/s00247-011-2295-9. Epub 2011 Nov 4.
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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.
Richard A Jones, PhD principal investigator
Department of Radiology, Emory 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 Cervical Spondylosis With Myelopathy, run by Emory University at 1 site in United States.
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 2 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 15 Jul 2015. 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 United States. 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?
Diffusion properties of the spinal cord (time frame: The diffusion properties are measured in a single imaging session lasting approximately 50 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868958, which also lists 1 linked publication.
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 15 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.