Multiple SclerosisTHALNUC-MSNCT05002764
Thalamic Nuclei Volumes in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 Jul 2023
- How long will I take part?
- 24 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Multiple Sclerosis and at least one MRI that includes 3D T1 and FLAIR at 1.5T or 3T.
Who may be able to join
- 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.
Who cannot join
- Stroke
- Other causes of dementia not caused by Multiple Sclerosis (Alzheimer's disease, Parkinsonian syndromes…)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33 076
Thomas TOURDIAS, Pr, 05 56 79 56 04, thomas.tourdias@chu-bordeaux.fr
About this study
Official title: Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis
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
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Thalamus, Nuclei, Atrophy
- Medical subject headings
- Multiple Sclerosis, Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of thalamic nuclei
Volume of individual thalamic nuclei according to disease duration.
Measured: At inclusion in the cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 24 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002764
- Sponsor's protocol ID
- CHUBX 2021/33
- Acronym
- THALNUC-MS
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05002764
- Acronym / sponsor ID
- THALNUC-MS / CHUBX 2021/33
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Thalamus, Nuclei, Atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis and at least one MRI that includes 3D T1 and FLAIR at 1.5T or 3T.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Stroke
- Other causes of dementia not caused by Multiple Sclerosis (Alzheimer's disease, Parkinsonian syndromes…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of thalamic nuclei
Time frame: At inclusion in the cohort
Volume of individual thalamic nuclei according to disease duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Tourdias, Pr (05 56 79 56 04, thomas.tourdias@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of thalamic nuclei (time frame: At inclusion in the cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.