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

October 18, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75014
        • Cochin Hospital, Radiology B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DTI parameters in cervical spinal cord
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Antoine FEYDY, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (Estimate)

November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P090404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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