Default Mode Network in Multiple Sclerosis (CONNECT-15)

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: neuropsychological battery; Other: resting state functional magnetic resonance image (rs-fMRI)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon
    • Contact: María Luisa Martínez-Ginés, MD; Phone Number: +34914269610; Email: marisamgines@hotmail.com
    • Contact: Yolanda Higueras, PhD; Phone Number: 915868339; Email: yolandahigueras@googlemail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: neuropsychological battery; neuropsychological battery including cognitive and behavioural tests; Other: resting state functional magnetic resonance image (rs-fMRI); rs-fMRI
Other: 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	Other: resting state functional magnetic resonance image (rs-fMRI); rs-fMRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon
• Investigators: Principal Investigator: María Luisa Martínez-Ginés, MD, Hospital General Universitario Gregorio Marañon

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CONNECT-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No