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Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM). (NeuroRehEM)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
N-back Cognitive Training
Virtual Reality Motor and Cognitive Training
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Magnetic Resonance Imaging, Neuroplasticity, Cognitive Impairment, Virtual Reality

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Multiple Sclerosis Diagnosis.

Exclusion Criteria:

  • Other neurological pathologies comorbidity.
  • Magnetic resonance imaging incompatibilities.
  • Motor impairment degree that impede the task performance.

Sites / Locations

  • Universitat Jaume I (ImagoBrain Research Group)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Working Memory Training in MS patients

Virtual Reality Training in MS patients

Arm Description

This group of patients will perform a computerized n-back training, which includes a sequence of 2-back and 3-back blocks.

This group of patients will perform a Virtual Reality "Ball Task" training. This task contains 6 trials of increasing difficulty.

Outcomes

Primary Outcome Measures

Change from baseline in Correct Responses
Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Change from baseline in Reaction Time
This is a primary outcome of the n-back task, which refers to the amount of time (in milliseconds) that elapse from the moment the correct stimulus appears and the correct response is given.
Change from baseline in Omissions
In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Change from baseline in Errors
The number of times that a distractor stimulus appears and a response is given.
Change from baseline in Functional Connectivity in resting state
This is a brain activity measure during resting state through functional magnetic resonance imaging. This outcome will be assessed in both studies. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in Functional Connectivity in task performance
This is a brain activity measure during a task performance through functional magnetic resonance imaging. This outcome will be assessed in Virtual Reality study. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in SRT-S: Selective Reminding Test (Storing)
A subtest of the BRB-N (The Brief Repeatable Battery of Neuropsychological Tests for MS) which measures memory storage capacity.
Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
This subtest of the BRB-N is a measure of memory retrieval capacity.
Change from baseline in SRT-D: Selective Reminding Test (Delayed)
This BRB-N subtest measures the delayed memory.
Change from baseline in SPART: Spatial Recall Test
A subtest of the BRB-N that measures spatial memory.
Change from baseline in SPART-D: Spatial Recall Test (Delayed)
This BRB-N subtest measures the spatial delayed memory.
Change from baseline in SDMT: Symbol Digit Modalities Test
A BRB-N subtest which measures information processing speed.
Change from baseline in PASAT: Paced Auditory Serial Addition Task
A BRB-N subtest which measures working memory.
Change from baseline in Phonemic Fluency
A language measure that assesses phonemic fluency.
Change from baseline in Semantic Fluency
A language measure that assesses semantic fluency.
Change from baseline in Digit Span Forward
A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
Change from baseline in Digit Span Backward
A WAIS-III subtest that is a working memory measure.
Change from baseline in Letters and Numbers
A WAIS-III subtest that measures working memory.

Secondary Outcome Measures

Total Intracraneal Volume (TIV)
A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.
Brain Parenchimal Fraction (BPF)
MRI sequence: structural T1-weighted MPRAGE sequence.
Lesion Volume in white matter tissue
A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence
Cortical Lesions
Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).
Cortical Thickness
Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.

Full Information

First Posted
January 31, 2022
Last Updated
November 15, 2022
Sponsor
Universitat Jaume I
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1. Study Identification

Unique Protocol Identification Number
NCT05270239
Brief Title
Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).
Acronym
NeuroRehEM
Official Title
Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I

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
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are: to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game. to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs to observe the role of the atrophy in brain neuroplasticity processes. Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Magnetic Resonance Imaging, Neuroplasticity, Cognitive Impairment, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Working Memory Training in MS patients
Arm Type
Experimental
Arm Description
This group of patients will perform a computerized n-back training, which includes a sequence of 2-back and 3-back blocks.
Arm Title
Virtual Reality Training in MS patients
Arm Type
Experimental
Arm Description
This group of patients will perform a Virtual Reality "Ball Task" training. This task contains 6 trials of increasing difficulty.
Intervention Type
Behavioral
Intervention Name(s)
N-back Cognitive Training
Intervention Description
N-back task mainly trains working memory and information processing speed. This training lasts 10 days (1 hour per day).
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Motor and Cognitive Training
Intervention Description
Virtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day)
Primary Outcome Measure Information:
Title
Change from baseline in Correct Responses
Description
Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Reaction Time
Description
This is a primary outcome of the n-back task, which refers to the amount of time (in milliseconds) that elapse from the moment the correct stimulus appears and the correct response is given.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Omissions
Description
In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Errors
Description
The number of times that a distractor stimulus appears and a response is given.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Functional Connectivity in resting state
Description
This is a brain activity measure during resting state through functional magnetic resonance imaging. This outcome will be assessed in both studies. fMRI sequence: T2-weighted echoplanar imaging sequence.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Functional Connectivity in task performance
Description
This is a brain activity measure during a task performance through functional magnetic resonance imaging. This outcome will be assessed in Virtual Reality study. fMRI sequence: T2-weighted echoplanar imaging sequence.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SRT-S: Selective Reminding Test (Storing)
Description
A subtest of the BRB-N (The Brief Repeatable Battery of Neuropsychological Tests for MS) which measures memory storage capacity.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
Description
This subtest of the BRB-N is a measure of memory retrieval capacity.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SRT-D: Selective Reminding Test (Delayed)
Description
This BRB-N subtest measures the delayed memory.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SPART: Spatial Recall Test
Description
A subtest of the BRB-N that measures spatial memory.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SPART-D: Spatial Recall Test (Delayed)
Description
This BRB-N subtest measures the spatial delayed memory.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in SDMT: Symbol Digit Modalities Test
Description
A BRB-N subtest which measures information processing speed.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in PASAT: Paced Auditory Serial Addition Task
Description
A BRB-N subtest which measures working memory.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Phonemic Fluency
Description
A language measure that assesses phonemic fluency.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Semantic Fluency
Description
A language measure that assesses semantic fluency.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Digit Span Forward
Description
A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Digit Span Backward
Description
A WAIS-III subtest that is a working memory measure.
Time Frame
Baseline and 10 training days after.
Title
Change from baseline in Letters and Numbers
Description
A WAIS-III subtest that measures working memory.
Time Frame
Baseline and 10 training days after.
Secondary Outcome Measure Information:
Title
Total Intracraneal Volume (TIV)
Description
A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.
Time Frame
Baseline
Title
Brain Parenchimal Fraction (BPF)
Description
MRI sequence: structural T1-weighted MPRAGE sequence.
Time Frame
Baseline
Title
Lesion Volume in white matter tissue
Description
A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence
Time Frame
Baseline
Title
Cortical Lesions
Description
Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).
Time Frame
Baseline
Title
Cortical Thickness
Description
Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple Sclerosis Diagnosis. Exclusion Criteria: Other neurological pathologies comorbidity. Magnetic resonance imaging incompatibilities. Motor impairment degree that impede the task performance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Forn
Phone
+34 964 38 7658
Email
forn@uji.psb.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Forn
Organizational Affiliation
Universitat Jaume I (Castellón, Spain)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carla Sanchis
Organizational Affiliation
Universitat Jaume I (Castellón, Spain)
Official's Role
Study Director
Facility Information:
Facility Name
Universitat Jaume I (ImagoBrain Research Group)
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Forn
Phone
+34 964 387658
Email
forn@uji.psb.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not foreseen due to the ethics committee's privacy policy on the protection of personal data. However, upon request, radiological data could be shared.
Citations:
PubMed Identifier
25857687
Citation
Baltruschat SA, Ventura-Campos N, Cruz-Gomez AJ, Belenguer A, Forn C. Gray matter atrophy is associated with functional connectivity reorganization during the Paced Auditory Serial Addition Test (PASAT) execution in Multiple Sclerosis (MS). J Neuroradiol. 2015 Jun;42(3):141-9. doi: 10.1016/j.neurad.2015.02.006. Epub 2015 Apr 6.
Results Reference
background
PubMed Identifier
23828871
Citation
Cruz-Gomez AJ, Ventura-Campos N, Belenguer A, Avila C, Forn C. The link between resting-state functional connectivity and cognition in MS patients. Mult Scler. 2014 Mar;20(3):338-48. doi: 10.1177/1352458513495584. Epub 2013 Jul 4.
Results Reference
background
PubMed Identifier
25998261
Citation
Mitolo M, Venneri A, Wilkinson ID, Sharrack B. Cognitive rehabilitation in multiple sclerosis: A systematic review. J Neurol Sci. 2015 Jul 15;354(1-2):1-9. doi: 10.1016/j.jns.2015.05.004. Epub 2015 May 9.
Results Reference
background
PubMed Identifier
33964569
Citation
Aguirre N, Cruz-Gomez AJ, Esbri SF, Miro-Padilla A, Bueicheku E, Broseta-Torres R, Avila C, Sanchis-Segura C, Forn C. Enhanced frontoparietal connectivity in multiple sclerosis patients and healthy controls in response to an intensive computerized training focused on working memory. Mult Scler Relat Disord. 2021 Jul;52:102976. doi: 10.1016/j.msard.2021.102976. Epub 2021 Apr 24.
Results Reference
background
PubMed Identifier
29497559
Citation
Sandroff BM, Wylie GR, Sutton BP, Johnson CL, DeLuca J, Motl RW. Treadmill walking exercise training and brain function in multiple sclerosis: Preliminary evidence setting the stage for a network-based approach to rehabilitation. Mult Scler J Exp Transl Clin. 2018 Feb 21;4(1):2055217318760641. doi: 10.1177/2055217318760641. eCollection 2018 Jan-Mar.
Results Reference
background
PubMed Identifier
31139470
Citation
Aguirre N, Cruz-Gomez AJ, Miro-Padilla A, Bueicheku E, Broseta Torres R, Avila C, Sanchis-Segura C, Forn C. Repeated Working Memory Training Improves Task Performance and Neural Efficiency in Multiple Sclerosis Patients and Healthy Controls. Mult Scler Int. 2019 Apr 16;2019:2657902. doi: 10.1155/2019/2657902. eCollection 2019.
Results Reference
background

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Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).

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