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Clinical Trials/NCT01243684
NCT01243684
Completed
Not 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 enrollmentSeptember 1, 2010

Overview

Phase
Not Applicable
Intervention
DTI - Diffusor Tensor Imaging
Conditions
Cervical Spondylosis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
40
Locations
2
Primary Endpoint
DTI parameters in cervical spinal cord
Status
Completed
Last Updated
2 months ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2010
End Date
January 1, 2014
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Patients

Intervention: DTI - Diffusor Tensor Imaging

Healty volunteers

Intervention: DTI - Diffusor Tensor Imaging

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)

Study Sites (2)

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