Default Mode Network in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CONNECT-15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810314
• Other study ID #: CONNECT-15
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: María Luisa Martínez-Ginés, MD
• Phone: 34914269610
• Email: marisamgines[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• neuropsychological battery
neuropsychological battery including cognitive and behavioural tests

Other:
• resting state functional magnetic resonance image (rs-fMRI)
rs-fMRI

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of functional connectivity of default mode network (DMN)	measure is taken with fMRI	at study entry and after 12 months
Secondary	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
Secondary	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