NCT01243684

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

November 12, 2010

Last Update Submit

February 11, 2026

Conditions

Cervical Spondylosis

Keywords

Spinal cordcervical spondylosismyelopathy

Outcome Measures

Primary Outcomes (1)

  • DTI parameters in cervical spinal cord

    3 weeks

Secondary Outcomes (1)

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

    3 weeks

Study Arms (2)

Healty volunteers

ACTIVE COMPARATOR
Device: DTI - Diffusor Tensor Imaging

Patients

EXPERIMENTAL
Device: DTI - Diffusor Tensor Imaging

Interventions

DTI - Diffusor Tensor ImagingDEVICE

Radiology intervention

Healty volunteersPatients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Sufficiently cooperative
  • Cognitively understands study and implications
  • Signed informed consent
  • Symptomatic cervical spondylosis

You may not qualify if:

  • MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
  • Previous pathology that would impact behavioural measures
  • Anxiety and poor cooperation
  • Previous neurological condition
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital, Radiology B

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 26123409RESULT

MeSH Terms

Conditions

SpondylosisSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Antoine FEYDY, PhD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 18, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2012

Study Completion

January 1, 2014

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

FR(1)