A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis

Not Applicable

Completed

• Conditions: Cervical Spondylosis
• Interventions: Device: DTI - Diffusor Tensor Imaging

• Registration Number: NCT01243684
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2012-06
• Study Completion: 2014-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healty volunteers	DTI - Diffusor Tensor Imaging	-
Patients	DTI - Diffusor Tensor Imaging	-

Primary Outcome Measures

Name	Time	Method
DTI parameters in cervical spinal cord	3 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength	3 weeks	Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity; Motor function (dexterity test), grip strength

Trial Locations

Locations (1)

Cochin Hospital, Radiology B; 🇫🇷 Paris, Ile de France, France