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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01243684
First received: November 12, 2010
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.


Condition Intervention
Cervical Spondylosis
Device: DTI - Diffusor Tensor Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • DTI parameters in cervical spinal cord [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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

    Motor function (dexterity test), grip strength



Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healty volunteers Device: DTI - Diffusor Tensor Imaging
Radiology intervention
Other Name: DTI - Diffusor Tensor Imaging
Experimental: Patients Device: DTI - Diffusor Tensor Imaging
Radiology intervention
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01243684     History of Changes
Other Study ID Numbers: P090404
Study First Received: November 12, 2010
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014