A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis

Cervical Spondylosis Clinical Trial

— Tractocervical  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243684
• Other study ID #: P090404
• Status: Completed
• Phase: N/A
• First received: November 12, 2010
• Last updated: October 18, 2015
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

Device:
• DTI - Diffusor Tensor Imaging
Radiology intervention

Locations

Country	Name	City	State
France	Cochin Hospital, Radiology B	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DTI parameters in cervical spinal cord		3 weeks	No
Secondary	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	3 weeks	No