Thalamic Nuclei Volumes in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— THALNUC-MS  

Official title:

Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002764
• Other study ID #: CHUBX 2021/33
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2021
• Source: University Hospital, Bordeaux
• Contact: Thomas Tourdias, Pr
• Phone: 05 56 79 56 04
• Email: thomas.tourdias[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The thalamus is composed of several nuclei interlocked in a complex anatomy. In multiple sclerosis (MS), the thalamus can be altered due to disconnection by white matter lesions and due to direct damages that could be partly mediated by CSF. Due to such pathophysiology and complex anatomy, some nuclei could be more vulnerable to multiple sclerosis than others. We will test this hypothesis by using a new algorithm to automatically segment several nuclei that we will be applied to the French national MS database

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Patient older than 18 years old.

• With Multiple Sclerosis according to Mc Donald 2017 criteria or with clinically isolated syndrome and included with OFSEP cohort.

• Phenotype known (RR, SP, PP or CIS).

• Date of diagnosis known.

• With at least one MRI that includes 3D T1 and FLAIR at 1.5T or 3T.

Exclusion Criteria :

• Stroke

• Other causes of dementia not caused by Multiple Sclerosis (Alzheimer's disease, Parkinsonian syndromes…)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of thalamic nuclei	Volume of individual thalamic nuclei according to disease duration.	At inclusion in the cohort