Default Mode Network in Multiple Sclerosis (CONNECT-15)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
neuropsychological battery
resting state functional magnetic resonance image (rs-fMRI)
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Hospital General Universitario Gregorio MarañónRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Clinical measures
Control measures
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change of functional connectivity of default mode network (DMN)
measure is taken with fMRI
Secondary Outcome Measures
Correlate grey matter indexes and cognitive functioning indexes
Two measures will be correlated: baseline and after 12 months
Correlate grey matter indexes and emotional/behavioural indexes
Two measures will be correlated: baseline and after 12 months
Full Information
NCT ID
NCT02810314
First Posted
June 15, 2016
Last Updated
February 9, 2021
Sponsor
Hospital General Universitario Gregorio Marañon
1. Study Identification
Unique Protocol Identification Number
NCT02810314
Brief Title
Default Mode Network in Multiple Sclerosis
Acronym
CONNECT-15
Official Title
Study of Default Mode Network (DMN) on Patients With Multiple Sclerosis (MS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Gregorio Marañon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical measures
Arm Type
Experimental
Arm Description
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
Arm Title
Control measures
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological battery
Intervention Description
neuropsychological battery including cognitive and behavioural tests
Intervention Type
Other
Intervention Name(s)
resting state functional magnetic resonance image (rs-fMRI)
Intervention Description
rs-fMRI
Primary Outcome Measure Information:
Title
Change of functional connectivity of default mode network (DMN)
Description
measure is taken with fMRI
Time Frame
at study entry and after 12 months
Secondary Outcome Measure Information:
Title
Correlate grey matter indexes and cognitive functioning indexes
Description
Two measures will be correlated: baseline and after 12 months
Time Frame
at study entry and after 12 months
Title
Correlate grey matter indexes and emotional/behavioural indexes
Description
Two measures will be correlated: baseline and after 12 months
Time Frame
at study entry and after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Luisa Martínez-Ginés, MD
Phone
34914269610
Email
marisamgines@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yolanda Higueras, PhD
Phone
34914269610
Email
yolanda.higueras@iisgm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Luisa Martínez-Ginés, MD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Higueras, PhD
Phone
915868339
Email
yolandahigueras@googlemail.com
First Name & Middle Initial & Last Name & Degree
María Luisa Martínez-Ginés, MD
Phone
+34914269610
Email
marisamgines@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Default Mode Network in Multiple Sclerosis
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