Healthy VolunteerTRACTOCORDNCT05079945
Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas
A study testing Spinal cord Tractography in order to differentiate spinal tracts. in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Spinal cord Tractography in order to differentiate spinal tracts.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2022to 30 Apr 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient> 18 years old
- Healthy volunteer
- Social insured in France
- Patient who signed the informed consent of the study
Who cannot join
- Medical or surgical history of disease that may affect the central nervous system, or the spine
- History of spine or spinal cord trauma.
- Spinal osteoarthritis which can lead to a medullary hyper signal.
- Contraindication to MRI: claustrophobia, pace-maker, defibrillator, metallic foreign bodies, etc.
- Subjects benefiting from legal protection (curatorship, guardianship or safeguard of justice).
- Pregnant and / or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs.
The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.
- Conditions
- Healthy Volunteer
- Being tested
- Spinal cord Tractography in order to differentiate spinal tracts.
- Keywords
- Tractography, DTI, MRI, spinal cord
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord Tractography in order to differentiate spinal tracts.Procedure or surgery
Spinal cord tractography using DTI MRI sequences of the brain and spinal cord, in order to differentiate tracts at the spinal cord level; and by performing a stitching process between Brain and Spinal cord DTI sequences.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord Tractography | Experimental | Healthy volunteer having the tractography exam Receives: Procedure: Spinal cord Tractography in order to differentiate spinal tracts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal tracts differentiation and identification
Percentage of complete tracts identified among healthy volunteer
Measured: date of Tractography procedure (DTI MRI)
Secondary outcomes (1)
Spinal cord Tracts Atlas
Elaboration of a tracts classification using a algorithm based on the type, the volume and the fraction of anisotropy and mean diffusivity of each tract
Measured: 12 months (end of recruitment and exams)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start5 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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 Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAULEAC Corentin, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079945
- Sponsor's protocol ID
- 69HCL21_0265
- Other IDs
- 2021-A02277-34
- Acronym
- TRACTOCORD
- Status last verified
- Aug 2025
- First submitted
- 21 Sep 2021
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dauleac C, Mertens P, Frindel C, Jacquesson T, Cotton F. Atlas-guided brain projection tracts: From regions of interest to tractography 3D rendering. J Anat. 2025 May;246(5):732-744. doi: 10.1111/joa.14120. Epub 2024 Aug 11.
PubMed 39129322
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas
- ClinicalTrials.gov ID
- NCT05079945
- Acronym / sponsor ID
- TRACTOCORD / 69HCL21_0265
- Conditions
- Healthy Volunteer
- Keywords
- Tractography, DTI, MRI, spinal cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- 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.
Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs.
The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord Tractography | Experimental | Procedure: Spinal cord Tractography in order to differentiate spinal tracts.Healthy volunteer having the tractography exam |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient> 18 years old
- Healthy volunteer
- Social insured in France
- Patient who signed the informed consent of the study
Key exclusion criteria (6 listed)
- Medical or surgical history of disease that may affect the central nervous system, or the spine
- History of spine or spinal cord trauma.
- Spinal osteoarthritis which can lead to a medullary hyper signal.
- Contraindication to MRI: claustrophobia, pace-maker, defibrillator, metallic foreign bodies, etc.
- Subjects benefiting from legal protection (curatorship, guardianship or safeguard of justice).
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 |
|---|---|---|
| Spinal cord Tractography in order to differentiate spinal tracts.Spinal cord tractography using DTI MRI sequences of the brain and spinal cord, in order to differentiate tracts at the spinal cord level; and by performing a stitching process between Brain and Spinal cord DTI sequences. | Procedure or surgery | Spinal cord Tractography |
Primary outcome
Spinal tracts differentiation and identification
Time frame: date of Tractography procedure (DTI MRI)
Percentage of complete tracts identified among healthy volunteer
1 secondary outcome
Spinal cord Tracts Atlas
Time frame: 12 months (end of recruitment and exams)
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 3 Sep 2025.
- Background: PubMed 39129322Dauleac C, Mertens P, Frindel C, Jacquesson T, Cotton F. Atlas-guided brain projection tracts: From regions of interest to tractography 3D rendering. J Anat. 2025 May;246(5):732-744. doi: 10.1111/joa.14120. Epub 2024 Aug 11.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
DAULEAC Corentin, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord Tractography in order to differentiate spinal tracts. in people with Healthy Volunteer, run by Hospices Civils de Lyon 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 4 inclusion and 6 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 3 Sep 2025. 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?
Spinal tracts differentiation and identification (time frame: date of Tractography procedure (DTI MRI)). 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 NCT05079945, 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 3 Sep 2025.