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

NCT ID: NCT05270239

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2023-07-31

Brief Summary

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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:

1. 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.
2. to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs
3. 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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Working Memory Training in MS patients

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

Group Type EXPERIMENTAL

N-back Cognitive Training

Intervention Type BEHAVIORAL

N-back task mainly trains working memory and information processing speed. This training lasts 10 days (1 hour per day).

Virtual Reality Training in MS patients

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

Group Type EXPERIMENTAL

Virtual Reality Motor and Cognitive Training

Intervention Type BEHAVIORAL

Virtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day)

Interventions

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N-back Cognitive Training

N-back task mainly trains working memory and information processing speed. This training lasts 10 days (1 hour per day).

Intervention Type BEHAVIORAL

Virtual Reality Motor and Cognitive Training

Virtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Multiple Sclerosis Diagnosis.

Exclusion Criteria

* Other neurological pathologies comorbidity.
* Magnetic resonance imaging incompatibilities.
* Motor impairment degree that impede the task performance.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristina Forn

Role: STUDY_DIRECTOR

Universitat Jaume I (Castellón, Spain)

Carla Sanchis

Role: STUDY_DIRECTOR

Universitat Jaume I (Castellón, Spain)

Locations

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Universitat Jaume I (ImagoBrain Research Group)

Castellon, Castellón, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 25857687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23828871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25998261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33964569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29497559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31139470 (View on PubMed)

Other Identifiers

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PID2019-106793RB-I00

Identifier Type: -

Identifier Source: org_study_id

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