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Clinical Trials/NCT01243684
NCT01243684CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris2 sites in 1 country40 target enrollmentStarted: September 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
DTI parameters in cervical spinal cord

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Patients

Experimental

Intervention: DTI - Diffusor Tensor Imaging (Device)

Healty volunteers

Active Comparator

Intervention: DTI - Diffusor Tensor Imaging (Device)

Outcomes

Primary Outcomes

DTI parameters in cervical spinal cord

Time Frame: 3 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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