Spinal Cord InjuryNCT01407705
High-Resolution Diffusion Tensor Imaging (DTI) of the Cervical Spinal Cord in the Setting of Spinal Cord Injury (SCI)
An observational study of Spinal Cord Injury and Cervical Spondylosis With Myelopathy, run by University of Utah at 1 site in United States.
Trial summary
The investigators propose a prospective study, designed to analyze the efficacy of High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in subjects with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Cervical Spondylosis With Myelopathy, Degenerative Disorder
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
Who may be able to join
- For inclusion to the Cervical Spinal Cord (CSM)
- Clinical and Radiographic evidence of cervical spondylotic myelopathy
- 18 to 80 years of age
- Safe and stable clinical scenario to undergo imaging
- Awake, alert patient able to cooperate with physical examination
- Give written informed consent prior to any testing under this protocol
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- For inclusion to the Control Group, subject must have:
- No diagnosis of cervical degenerative or traumatic disease
- 30 to 80 years of age
- Ability of volunteers to tolerate 1 hr examination
- For inclusion to the Degenerative Disease Group, subject must:
- Have signs or symptoms consistent with spinal cord injury.
- Be diagnosed with cervical spondylosis (degenerative disease).
- For inclusion to the Traumatic Group, subject must have:
- A spinal cord injury associated with a traumatic event.
Who cannot join
- For exclusion to the Cervical Spinal Cord (CSM):
- Unsafe or unstable clinical scenario
- Prior cervical spine surgery
- History of neurological disease (stroke, multiple sclerosis, peripheral neuropathy, or other neurodegenerative conditions)
- Inability to comply with physical examination
- Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..)
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- Pregnant women
- For exclusion to the other groups:
- Inability to comply with physical examination
- Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
The investigators propose a prospective study, designed to analyze the efficacy of High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in subjects with spinal cord injury. Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
Read the detailed description
Spinal cord injury (SCI) can result from trauma as well as degenerative conditions, such as cervical spondylotic myelopathy (CSM). Both have a profound impact on the physical and mental health of the affected individual. The symptoms of CSM can include weakness in the arms or legs, difficulty with walking and balance, loss of dexterity in the hands, and bowel or bladder dysfunction. Traumatic spinal cord injury often includes damage to white matter tracts resulting in irreversible functional deficits such as paraplegia or quadriplegia.
Although current diagnostic imaging can reveal highly specific parameters of spinal canal anatomy, the functional anatomy of the spinal cord remains unknown. Patients with similar diagnostic findings can vary clinically with many patients having minimal to no symptoms while others may be severely incapacitated. Conventional MRI methods, such as T1/T2 weighted MRI, may easily identify the region of the damage and may depict permanent changes in the spinal cord tissue. However, conventional MRI methods are limited in their ability to correlate imaging findings with short and long term functional outcomes from spinal cord injury. DTI has the potential to improve upon conventional MRI imaging by providing information about tissue microstructure and may be particularly well suited for assessing the integrity of fiber tracts in SCI.
Diffusion tensor magnetic resonance imaging (DTI) is a new technique that is highly sensitive in detecting the integrity of white matter tracts. Although information obtained from DTI has been utilized for white matter abnormalities in the brain, DTI of the spinal cord in vivo has provided many challenges. The small size of the spinal cord and the close packing of its white matter tracts require a very high image resolution to visualize these individual tracts. The resolution required to image the small cross sectional area of the spinal cord has been difficult to achieve using most widely used DTI sequences. To date, DTI measurements reports have demonstrated a practical application of DTI on the cervical spinal cord with limited spatial resolutions from 8 mm3 to 16 mm3.
To achieve high-resolution DTI of the spinal cord, two novel imaging techniques for high-resolution in-vivo DTI on a clinical 3T MRI system (Trio, Siemens Medical Solution, Erlangen Germany) have been developed: 2D singleshot Interleaved Multiple Inner Volume DWEPI (ss-IMIV-DWEPI) and 3D singleshot DW STimulated EPI (3D ss-DWSTEPI). These optimized DTI pulse sequences have typically achieved approximately 2.0 or 1.253 mm3 spatial resolution within clinically achievable imaging time (~5 min.). The sequences have been designed especially for high-resolution DTI of cervical spinal cord. They have been applied to spinal cord specimens ex vivo as well as to a small group of healthy volunteers and multiple sclerosis patients.
- Keywords
- spinal cord injury with traumatic event
- Medical subject headings
- Spinal Cord Injuries
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 |
|---|---|---|
| Control Group | * No diagnosis of cervical degenerative or traumatic disease * 30 to 80 years of age * Ability of volunteers to tolerate 1 hr examination | |
| Disease (Non-healthy) Group | Cervical Spinal Cord: * Clinical and Radiographic evidence of cervical spondylotic myelopathy * 18 to 80 years of age * Safe and stable clinical scenario to undergo imaging * Awake, alert patient able to cooperate with physical examination * Give written informed consent prior to any testing under this protocol Degenerative Disease Group: * Have signs or symptoms consistent with spinal cord injury. * Be diagnosed with cervical spondylosis (degenerative disease). Traumatic Group: • A spinal cord injury associated with a traumatic event. |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-resolution DTI of cervical spinal cord
To determine the efficacy of high-resolution diffusion weighted pulse sequence with spatial resolution of 2.0 mm3 to confirm directionality and intactness of cervical spinal cord tracts in vivo in the setting of spinal cord injury and disease-free subjects.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startMay 2007
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Lawrence, University of Utah
- Investigators
- Brandon Lawrence, MD, Principal investigator, University of Utah Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407705
- Sponsor's protocol ID
- 22962
- Status last verified
- May 2014
- First submitted
- 29 Jul 2011
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Diffusion Tensor Imaging (DTI) of the Cervical Spinal Cord in the Setting of Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT01407705
- Acronym / sponsor ID
- 22962
- Keywords
- spinal cord injury with traumatic event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Aug 2011 (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.
The investigators propose a prospective study, designed to analyze the efficacy of High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in subjects with spinal cord injury. Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
Detailed description
Spinal cord injury (SCI) can result from trauma as well as degenerative conditions, such as cervical spondylotic myelopathy (CSM). Both have a profound impact on the physical and mental health of the affected individual. The symptoms of CSM can include weakness in the arms or legs, difficulty with walking and balance, loss of dexterity in the hands, and bowel or bladder dysfunction. Traumatic spinal cord injury often includes damage to white matter tracts resulting in irreversible functional deficits such as paraplegia or quadriplegia.
Although current diagnostic imaging can reveal highly specific parameters of spinal canal anatomy, the functional anatomy of the spinal cord remains unknown. Patients with similar diagnostic findings can vary clinically with many patients having minimal to no symptoms while others may be severely incapacitated. Conventional MRI methods, such as T1/T2 weighted MRI, may easily identify the region of the damage and may depict permanent changes in the spinal cord tissue. However, conventional MRI methods are limited in their ability to correlate imaging findings with short and long term functional outcomes from spinal cord injury. DTI has the potential to improve upon conventional MRI imaging by providing information about tissue microstructure and may be particularly well suited for assessing the integrity of fiber tracts in SCI.
Diffusion tensor magnetic resonance imaging (DTI) is a new technique that is highly sensitive in detecting the integrity of white matter tracts. Although information obtained from DTI has been utilized for white matter abnormalities in the brain, DTI of the spinal cord in vivo has provided many challenges. The small size of the spinal cord and the close packing of its white matter tracts require a very high image resolution to visualize these individual tracts. The resolution required to image the small cross sectional area of the spinal cord has been difficult to achieve using most widely used DTI sequences. To date, DTI measurements reports have demonstrated a practical application of DTI on the cervical spinal cord with limited spatial resolutions from 8 mm3 to 16 mm3.
To achieve high-resolution DTI of the spinal cord, two novel imaging techniques for high-resolution in-vivo DTI on a clinical 3T MRI system (Trio, Siemens Medical Solution, Erlangen Germany) have been developed: 2D singleshot Interleaved Multiple Inner Volume DWEPI (ss-IMIV-DWEPI) and 3D singleshot DW STimulated EPI (3D ss-DWSTEPI). These optimized DTI pulse sequences have typically achieved approximately 2.0 or 1.253 mm3 spatial resolution within clinically achievable imaging time (~5 min.). The sequences have been designed especially for high-resolution DTI of cervical spinal cord. They have been applied to spinal cord specimens ex vivo as well as to a small group of healthy volunteers and multiple sclerosis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –* No diagnosis of cervical degenerative or traumatic disease * 30 to 80 years of age * Ability of volunteers to tolerate 1 hr examination |
| Disease (Non-healthy) Group | – | –Cervical Spinal Cord: * Clinical and Radiographic evidence of cervical spondylotic myelopathy * 18 to 80 years of age * Safe and stable clinical scenario to undergo imaging * Awake, alert patient able to cooperate with physical examination * Give written informed consent prior to any testing under this protocol Degenerative Disease Group: * Have signs or symptoms consistent with spinal cord injury. * Be diagnosed with cervical spondylosis (degenerative disease). Traumatic Group: • A spinal cord injury associated with a traumatic event. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
Key inclusion criteria (15 listed)
- For inclusion to the Cervical Spinal Cord (CSM)
- No diagnosis of cervical degenerative or traumatic disease
- 30 to 80 years of age
- Ability of volunteers to tolerate 1 hr examination
- Have signs or symptoms consistent with spinal cord injury.
Key exclusion criteria (11 listed)
- For exclusion to the Cervical Spinal Cord (CSM):
- Inability to comply with physical examination
- Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..)
- Pregnant women
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
high-resolution DTI of cervical spinal cord
Time frame: 2 years
To determine the efficacy of high-resolution diffusion weighted pulse sequence with spatial resolution of 2.0 mm3 to confirm directionality and intactness of cervical spinal cord tracts in vivo in the setting of spinal cord injury and disease-free subjects.
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 21 May 2014.
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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.
Brandon Lawrence, MD principal investigator
University of Utah Orthopedics
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 Spinal Cord Injury and Cervical Spondylosis With Myelopathy, run by University of Utah 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 15 inclusion and 11 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 21 May 2014. 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?
high-resolution DTI of cervical spinal cord (time frame: 2 years). 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 21 May 2014.