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

NCT01407705 | Completed

• 1 other identifier: 22962
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Cervical Spondylosis With Myelopathy; Degenerative Disorder

Keywords

spinal cord injury with traumatic event

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical and Radiographic evidence of cervical spondylotic myelopathy
• 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
• No diagnosis of cervical degenerative or traumatic disease
• to 80 years of age
• Ability of volunteers to tolerate 1 hr examination
• Have signs or symptoms consistent with spinal cord injury.
• Be diagnosed with cervical spondylosis (degenerative disease).
• A spinal cord injury associated with a traumatic event.

You may not qualify if:

• 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
• Inability to comply with physical examination
• Contraindications to MRI imaging (metal debris, cardiac pacemaker, etc..)
• Pregnant women

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Brandon Lawrence, MD

  University of Utah Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: May 1, 2007
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (1)