NCT02810314

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.4 years

First QC Date

June 15, 2016

Last Update Submit

February 9, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change of functional connectivity of default mode network (DMN)

    measure is taken with fMRI

    at study entry and after 12 months

Secondary Outcomes (2)

  • Correlate grey matter indexes and cognitive functioning indexes

    at study entry and after 12 months

  • Correlate grey matter indexes and emotional/behavioural indexes

    at study entry and after 12 months

Study Arms (2)

Clinical measures

EXPERIMENTAL

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

Control measures

OTHER

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)

Interventions

neuropsychological batteryBEHAVIORAL

neuropsychological battery including cognitive and behavioural tests

Clinical measures
resting state functional magnetic resonance image (rs-fMRI)OTHER

rs-fMRI

Clinical measuresControl measures

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • MS diagnostic following McDonald 2010 diagnosis criteria.
  • to 60 years old.
  • Consent form signature.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • María Luisa Martínez-Ginés, MD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Luisa Martínez-Ginés, MD

CONTACT

34914269610marisamgines@hotmail.com

Yolanda Higueras, PhD

CONTACT

34914269610yolanda.higueras@iisgm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurologist

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 22, 2016

Study Start

May 1, 2017

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)