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

Healthy Volunteer Clinical Trial

— TRACTOCORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079945
• Other study ID #: 69HCL21_0265
• Secondary ID: 2021-A02277-34
• Status: Completed
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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.

Locations

Country	Name	City	State
France	Dauleac Corentin	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal tracts differentiation and identification	Percentage of complete tracts identified among healthy volunteer	date of Tractography procedure (DTI MRI)
Secondary	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	12 months (end of recruitment and exams)