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

Primary Purpose

Cervical Spondylosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DTI - Diffusor Tensor Imaging
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Spondylosis focused on measuring Spinal cord, cervical spondylosis, myelopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cochin Hospital, Radiology B

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healty volunteers

Patients

Arm Description

Outcomes

Primary Outcome Measures

DTI parameters in cervical spinal cord

Secondary Outcome Measures

Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength
Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity Motor function (dexterity test), grip strength

Full Information

First Posted
November 12, 2010
Last Updated
October 18, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01243684
Brief Title
A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis
Acronym
Tractocervical
Official Title
Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis
Keywords
Spinal cord, cervical spondylosis, myelopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healty volunteers
Arm Type
Active Comparator
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DTI - Diffusor Tensor Imaging
Intervention Description
Radiology intervention
Primary Outcome Measure Information:
Title
DTI parameters in cervical spinal cord
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength
Description
Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity Motor function (dexterity test), grip strength
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine FEYDY, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital, Radiology B
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis

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