Default Mode Network in Multiple Sclerosis

Study Overview
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Brief Summary
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The study will evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, investigators will include patients with progressive evolution as well as initial forms of the disease (CIS) and properly established forms of multiple sclerosis (MS) in remittent-recidivant (RR) forms. The researches will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs.

Detailed Description
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To date, no clear consensus has been reached related to default mode network (DMN) activity and different clinical types of MS. Due to this controversy on the literature regarding increment and decrement of DMN activity along the natural history of MS evolution, this study aim to add experimental information and more data that might help to disentangle this paradox, also correlating this DMN activity with anatomic and cognitive indexes. The investigators will also introduce a novel experimental design, including a prospective measure of the investigators connectivity and cognitive measures. In this study, investigators aim to evaluate connectivity regardless whether patients present a clinical type that requires medical treatment. In this point, patients with progressive evolution as well as initial forms of the disease (CIS) will be included and properly established forms of MS in RR forms. Researchers will not focus on medical treatment as some of these clinical forms have no indication for disease modifying drugs. Nevertheless, investigators consider that the study of connectivity is worth regardless their pharmacological treatment. The investigators also aim to offer data on the natural history of MS evolution for distinct MS type patients and healthy controls, as this study is planned to collect data longitudinally.

Official Title
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Study of Default Mode Network (DMN) on Patients With Multiple Sclerosis (MS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: neuropsychological battery
* Other: resting state functional magnetic resonance image (rs-fMRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS diagnostic following McDonald 2010 diagnosis criteria. 18 to 60 years old. Consent form signature. Exclusion Criteria: Dementia diagnosis, following Spanish Neurological Society criteria. Mayor psychiatric illness. Physical or intellectual limitations to successfully perform - neuropsychological evaluation. Any other circumstance that may interfere with functional magnetic resonance session. Abnormal renal function previous to magnetic resonance image (MRI) session.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical measures<br>MS patients recruited for this study will complete a resting state functional magnetic resonance image (rs-fMRI) session that will provide information on how DMN network works for each group and all MS patients will also complete a comprehensive neuropsychological battery including cognitive and behavioural tests of interest in MS | Behavioral: neuropsychological battery<br>* neuropsychological battery including cognitive and behavioural tests<br>Other: resting state functional magnetic resonance image (rs-fMRI)<br>* rs-fMRI<br>|
| Other: Control measures<br>Healthy participants recruited for this study will complete a resting state functional magnetic resonance image (rs-fMRI) session that will provide information on how DMN network works | Other: resting state functional magnetic resonance image (rs-fMRI)<br>* rs-fMRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of functional connectivity of default mode network (DMN) | measure is taken with fMRI | at study entry and after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate grey matter indexes and cognitive functioning indexes | Two measures will be correlated: baseline and after 12 months | at study entry and after 12 months | 
| Correlate grey matter indexes and emotional/behavioural indexes | Two measures will be correlated: baseline and after 12 months | at study entry and after 12 months |