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Default Mode Network in Multiple Sclerosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02810314
Acronym
CONNECT-15
Enrollment
64
Registered
2016-06-22
Start date
2017-05-01
Completion date
2021-12-31
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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

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.

Interventions

neuropsychological battery including cognitive and behavioural tests

OTHERresting state functional magnetic resonance image (rs-fMRI)

rs-fMRI

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of functional connectivity of default mode network (DMN)at study entry and after 12 monthsmeasure is taken with fMRI

Secondary

MeasureTime frameDescription
Correlate grey matter indexes and cognitive functioning indexesat study entry and after 12 monthsTwo measures will be correlated: baseline and after 12 months
Correlate grey matter indexes and emotional/behavioural indexesat study entry and after 12 monthsTwo measures will be correlated: baseline and after 12 months

Countries

Spain

Contacts

Primary ContactMaría Luisa Martínez-Ginés, MD
marisamgines@hotmail.com34914269610
Backup ContactYolanda Higueras, PhD
yolanda.higueras@iisgm.com34914269610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026