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

Not Applicable

Completed

• Conditions: Healthy Volunteer
• Interventions: Procedure: Spinal cord Tractography in order to differentiate spinal tracts.

• Registration Number: NCT05079945
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Study Start: 2022-02-05
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal cord Tractography	Spinal cord Tractography in order to differentiate spinal tracts.	Healthy volunteer having the tractography exam

Primary Outcome Measures

Name	Time	Method
Spinal tracts differentiation and identification	date of Tractography procedure (DTI MRI)	Percentage of complete tracts identified among healthy volunteer

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dauleac Corentin; 🇫🇷 Bron, France