Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI)

NCT04224077 | Completed

• 1 other identifier: RC-P0060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by specifically evaluating the contribution of the multiband technique in healthy volunteers.

Conditions

Radiculopathy Lumbar; MRI; Diffusion Tensor Imaging

Keywords

Radiculopathy Lumbar; MRI; Diffusion tensor imaging; Multiband technique

Outcome Measures

Primary Outcomes (1)

• Image quality measured as signal-to-noise ratio and contrast-to-noise ratio

  Comparison of the image quality between DTI optimized and DTI of reference. The signal-to-noise ratio is a measure that compares the level of a desired signal to the level of background noise. Mathematically, the signal-to-noise ratio is the quotient of the (mean) signal intensity measured in a region of interest and the standard deviation of the signal intensity in a region outside the anatomy of the object being imaged. The contrast-to-noise ratio is a measure of image quality based on a contrast rather than the raw signal.

  Day 0

Secondary Outcomes (3)

• Fraction of anisotropy and apparent diffusion coefficient

  Day 0

• Concordance of observed agreement measured by Cohen's kappa coefficient

  Day 0

• Concordance of observed agreement measured by Intra-class correlation coefficient

  Day 0

Study Arms (1)

Intervention

EXPERIMENTAL

Healthy volunteers

Diagnostic Test: Optimisation of DTI sequences

Interventions

Optimisation of DTI sequences DIAGNOSTIC_TEST

Optimisation of DTI sequences in the study of lumbar roots by MRI

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Person without history of lumbar surgery
• Person who has previously consented

You may not qualify if:

• MRI contraindications (pace maker, cardiac defibrillator,...)
• Claustrophobia
• Pregnant woman
• Person without social security
• Person with a guardianship
• Person carrying metallic surgical material (spine, pelvis, abdomen)

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Lille Catholic Hospitals

Lomme, 59462, France

Location

Study Officials

• Jean-François BUDZIK, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 10, 2020
• Primary Completion: February 10, 2020
• Study Completion: August 31, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)