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A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis (Tractocervical)

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ClinicalTrials.gov Identifier: NCT01243684
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.

Condition or disease Intervention/treatment
Cervical Spondylosis Device: DTI - Diffusor Tensor Imaging

Detailed Description:
Diffusion tensor imaging (DTI) of the cervical spinal cord will be performed in patients with cervical spondylosis with varying degrees of symptoms and in healthy control subjects. Fibre tracking of main spinal tracts will be performed. Regions of interest will also be identified. Diffusion parameters will be extracted. This will allow quantification of degree of damage in of the spinal cord. The findings will be related to motor function measures and comprehensive clinical tests of sensory and motor function.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status
Study Start Date : September 2010
Primary Completion Date : June 2012
Study Completion Date : January 2014
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Healty volunteers Device: DTI - Diffusor Tensor Imaging
Radiology intervention
Experimental: Patients Device: DTI - Diffusor Tensor Imaging
Radiology intervention


Outcome Measures

Primary Outcome Measures :
  1. DTI parameters in cervical spinal cord [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength [ Time Frame: 3 weeks ]

    Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity

    Motor function (dexterity test), grip strength



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 years old
  • Sufficiently cooperative
  • Cognitively understands study and implications
  • Signed informed consent
  • Symptomatic cervical spondylosis

Exclusion Criteria:

  • MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
  • Previous pathology that would impact behavioural measures
  • Anxiety and poor cooperation
  • Previous neurological condition
  • Pregnancy
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): NCT01243684


Locations
France
Cochin Hospital, Radiology B
Paris, Ile de France, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Antoine FEYDY, PhD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01243684     History of Changes
Other Study ID Numbers: P090404
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Spinal cord
cervical spondylosis
myelopathy

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases