High-Resolution Diffusion Tensor Imaging (DTI) of the Cervical Spinal Cord in the Setting of Spinal Cord Injury (SCI)

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ClinicalTrials.gov Identifier: NCT01407705

Recruitment Status : Completed

First Posted : August 2, 2011

Last Update Posted : May 21, 2014

Sponsor:

Information provided by (Responsible Party):

Brandon Lawrence, University of Utah

Study Description

Brief 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. 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.

Condition or disease
Spinal Cord Injury Cervical Spondylosis With Myelopathy Degenerative Disorder

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


Study Type :	Observational
Actual Enrollment :	31 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	High-Resolution Diffusion Tensor Imaging (DTI) of the Cervical Spinal Cord in the Setting of Spinal Cord Injury (SCI)
Study Start Date :	May 2007
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diagnostic Imaging Spinal Cord Injuries

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

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.

Exclusion Criteria:

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..)
- 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407705

Locations


United States, Utah
University of Utah Orthopedics
Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

University of Utah

Investigators


Principal Investigator:	Brandon Lawrence, MD	University of Utah Orthopedics

More Information


Responsible Party:	Brandon Lawrence, M.D., University of Utah
ClinicalTrials.gov Identifier:	NCT01407705 History of Changes
Other Study ID Numbers:	22962
First Posted:	August 2, 2011 Key Record Dates
Last Update Posted:	May 21, 2014
Last Verified:	May 2014

Keywords provided by Brandon Lawrence, University of Utah:


spinal cord injury with traumatic event

Additional relevant MeSH terms:


Spinal Cord Diseases Wounds and Injuries Spinal Cord Injuries Spondylosis Spinal Osteophytosis Central Nervous System Diseases	Nervous System Diseases Trauma, Nervous System Spinal Diseases Bone Diseases Musculoskeletal Diseases

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