Default Mode Network in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinical measures

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

Group Type EXPERIMENTAL

neuropsychological battery

Intervention Type BEHAVIORAL

neuropsychological battery including cognitive and behavioural tests

resting state functional magnetic resonance image (rs-fMRI)

Intervention Type OTHER

rs-fMRI

Control measures

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

Group Type OTHER

resting state functional magnetic resonance image (rs-fMRI)

Intervention Type OTHER

rs-fMRI

Interventions

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neuropsychological battery

neuropsychological battery including cognitive and behavioural tests

Intervention Type BEHAVIORAL

resting state functional magnetic resonance image (rs-fMRI)

rs-fMRI

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes