Cervical SpondylosisTractocervicalNCT01243684
A Magnetic Resonance Imaging Study of Patients With Cervical Spondylosis
A study testing DTI - Diffusor Tensor Imaging in people with Cervical Spondylosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- DTI - Diffusor Tensor Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years old
- Sufficiently cooperative
- Cognitively understands study and implications
- Signed informed consent
- Symptomatic cervical spondylosis
Who cannot join
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
- Previous pathology that would impact behavioural measures
- Anxiety and poor cooperation
- Previous neurological condition
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status
This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.
Read the 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.
- Conditions
- Cervical Spondylosis
- Being tested
- DTI - Diffusor Tensor Imaging
- Keywords
- Spinal cord, cervical spondylosis, myelopathy
- Medical subject headings
- Spondylosis, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTI - Diffusor Tensor ImagingDevice
Radiology intervention
| Study group | Role | What they receive |
|---|---|---|
| Healty volunteers | Active comparator | Not described Receives: Device: DTI - Diffusor Tensor Imaging |
| Patients | Experimental | Not described Receives: Device: DTI - Diffusor Tensor Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
DTI parameters in cervical spinal cord
Measured: 3 weeks
Secondary outcomes (1)
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Antoine FEYDY, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243684
- Sponsor's protocol ID
- P090404
- Acronym
- Tractocervical
- Status last verified
- Feb 2026
- First submitted
- 12 Nov 2010
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26123409
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status
- ClinicalTrials.gov ID
- NCT01243684
- Acronym / sponsor ID
- Tractocervical / P090404
- Conditions
- Cervical Spondylosis
- Keywords
- Spinal cord, cervical spondylosis, myelopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healty volunteers | Active comparator | Device: DTI - Diffusor Tensor Imaging |
| Patients | Experimental | Device: DTI - Diffusor Tensor Imaging |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-70 years old
- Sufficiently cooperative
- Cognitively understands study and implications
- Signed informed consent
- Symptomatic cervical spondylosis
Key exclusion criteria (5 listed)
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
- Previous pathology that would impact behavioural measures
- Anxiety and poor cooperation
- Previous neurological condition
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTI - Diffusor Tensor ImagingRadiology intervention | Device | Healty volunteers, Patients |
Primary outcome
DTI parameters in cervical spinal cord
Time frame: 3 weeks
1 secondary outcome
Clinical data, i.e., Muscle testing, sensory testing, reflexes, spasticity, and Motor function (dexterity test), grip strength
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 26123409Lindberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine FEYDY, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTI - Diffusor Tensor Imaging in people with Cervical Spondylosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DTI parameters in cervical spinal cord (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01243684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.