A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis

NCT ID: NCT01243684

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cervical Spondylosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healty volunteers

Group Type ACTIVE_COMPARATOR

DTI - Diffusor Tensor Imaging

Intervention Type DEVICE

Radiology intervention

Patients

Group Type EXPERIMENTAL

DTI - Diffusor Tensor Imaging

Intervention Type DEVICE

Radiology intervention

Interventions

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DTI - Diffusor Tensor Imaging

Radiology intervention

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine FEYDY, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Cochin Hospital, Radiology B

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Lindberg PG, Sanchez K, Ozcan F, Rannou F, Poiraudeau S, Feydy A, Maier MA. Correlation of force control with regional spinal DTI in patients with cervical spondylosis without signs of spinal cord injury on conventional MRI. Eur Radiol. 2016 Mar;26(3):733-42. doi: 10.1007/s00330-015-3876-z. Epub 2015 Jun 27.

Reference Type BACKGROUND
PMID: 26123409 (View on PubMed)

Other Identifiers

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P090404

Identifier Type: -

Identifier Source: org_study_id

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