- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05079945
Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas (TRACTOCORD)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Dauleac Corentin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinal cord Tractography
Healthy volunteer having the tractography exam
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal tracts differentiation and identification
Time Frame: date of Tractography procedure (DTI MRI)
|
Percentage of complete tracts identified among healthy volunteer
|
date of Tractography procedure (DTI MRI)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal cord Tracts Atlas
Time Frame: 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
|
12 months (end of recruitment and exams)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DAULEAC Corentin, Dr, Hospices Civils de Lyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL21_0265
- 2021-A02277-34 (Other Identifier: N°ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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