Diffusion Tensor (Magnetic Resonance) Imaging and Tractography in Herniation of the Cervical Spine

NCT ID: NCT00599183

Last Updated: 2013-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-05-31

Brief Summary

This is an investigator-iniated pilot study to determine if MRI with diffusion tensor imaging (DTI) and tractography will yield useful information in patients suspected of having cervical spine disc herniation to provide imaging confirmation of whether or not disease is progressing and to assess response to treatment (regardless of treatment provided).

Detailed Description

Conventional MRI (magnetic resonance imaging) is used to confirm disc herniation of the cervical spine. Symptoms of the condition can change before they can be seen by conventional MR images. Therefore, very little gross change can be seen by conventional MRI even after 6 weeks of treatment, either medical or surgical. This study will investigate whether newer MRI techniques, diffusion tensor imaging (DTI) and tractography, are useful in demonstrating gross changes or assessing response to treatment.

Consenting patients referred for clinically indicated cervical spine MRI by their treating physicians to confirm cervical disc herniation will receive an additional MRI sequence, diffusion tensor imaging. This will provide a baseline. The DTI sequence will add five minutes to the procedure. Participants will return at 6 weeks for a follow up MRI of the cervical spine to include DTI and tractography. Participants will be asked to complete an anonymized questionnaire at enrollment and at follow up to provide information regarding their condition.

MRI is a non-invasive diagnostic study of minimal risk which uses magnets instead of ionizing radiation to acquire images. The images are then assembled by computer. Diffusion tensor imaging (DTI) uses water diffusion to visualize structures in the brain and nervous system. Tractography is performed using DTI and computer post-processing to track the fiber bundles which exist in the brain and spinal cord and visualize them as two and three dimensional images. Both techniques allow radiologists to detect abnormalities, in this case, cervical spine disc herniation.

The follow up studies will be compared to the baseline studies to determine which demonstrates the highest sensitivity and specificity in identifying cervical spine abnormalities in general and cervical spine herniation in particular.

Conditions

Cervical Spine Herniation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Participants will receive baseline conventional MRI of the cervical spine as part of their clinical care with an additional diffusion tensor imaging (DTI)sequence as part of the research; they will complete an anonymized questionnaire about their condition. Participants will receive an MRI with DTI and tractography as part of the research and will complete an anonymized questionnaire about their condition. The baseline and follow up data will be compared.

Group Type: OTHER

MRI-Diffusion Tensor Imaging and Tractrography

Intervention Type: OTHER

MRI scan: Baseline: Conventional MRI (as part of clinical care) with additional diffusion tensor imaging (DTI)sequence (research). 6-week follow up: MRI with DTI and tractography as part of the research

Interventions

MRI-Diffusion Tensor Imaging and Tractrography

MRI scan: Baseline: Conventional MRI (as part of clinical care) with additional diffusion tensor imaging (DTI)sequence (research). 6-week follow up: MRI with DTI and tractography as part of the research

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients suspected of having cervical spine herniation.

Exclusion Criteria

• Patients not suspected of having cervical spine herniation.
• Patients in which MRI is contraindicated (patients with embedded metallic objects, including pacemakers, surgical clips, spinal cord stimulators, or prosthetic heart valves.)
• Patients requiring general anesthesia or conscious sedation--sedation would increase risk to participants.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Franklin G. Moser, M.D.

Director, Neuro-Interventional Imaging; Vice Chair Radiology Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franklin Moser, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center - S. Mark Taper Foundation Imaging Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

CSMC IRB PRO00009246

Identifier Type: -

Identifier Source: org_study_id