TRACTOCORD: Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079945

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Procedure: Spinal cord Tractography in order to differentiate spinal tracts.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas

Actual Study Start Date :

Feb 5, 2022

Anticipated Primary Completion Date :

Feb 6, 2023

Anticipated Study Completion Date :

Feb 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinal cord Tractography Healthy volunteer having the tractography exam	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Spinal cord Tractography

Healthy volunteer having the tractography exam

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Spinal tracts differentiation and identification [date of Tractography procedure (DTI MRI)]
Percentage of complete tracts identified among healthy volunteer

Secondary Outcome Measures

Spinal cord Tracts Atlas [12 months (end of recruitment and exams)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dauleac Corentin	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: DAULEAC Corentin, Dr, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05079945

Other Study ID Numbers:

69HCL21_0265
2021-A02277-34

First Posted:

Oct 15, 2021

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Tractography, DTI, MRI, spinal cord

Study Results

No Results Posted as of Jun 22, 2022