NCT05079945

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

September 21, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

September 21, 2021

Last Update Submit

August 26, 2025

Conditions

Keywords

Tractography, DTI, MRI, spinal cord

Outcome Measures

Primary Outcomes (1)

  • Spinal tracts differentiation and identification

    Percentage of complete tracts identified among healthy volunteer

    date of Tractography procedure (DTI MRI)

Secondary Outcomes (1)

  • Spinal cord Tracts Atlas

    12 months (end of recruitment and exams)

Study Arms (1)

Spinal cord Tractography

EXPERIMENTAL

Healthy volunteer having the tractography exam

Procedure: Spinal cord Tractography in order to differentiate spinal tracts.

Interventions

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.

Spinal cord Tractography

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient\> 18 years old
  • Healthy volunteer
  • Social insured in France
  • Patient who signed the informed consent of the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dauleac Corentin

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 39129322BACKGROUND

Study Officials

  • DAULEAC Corentin, Dr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 15, 2021

Study Start

February 5, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations