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

NCT05270239 | Completed

• 1 other identifier: PID2019-106793RB-I00
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs
3. 3.to observe the role of the atrophy in brain neuroplasticity processes.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Magnetic Resonance Imaging; Neuroplasticity; Cognitive Impairment; Virtual Reality

Outcome Measures

Primary Outcomes (18)

• Change from baseline in Correct Responses

  Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)

  Baseline and 10 training days after.

• 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.

  Baseline and 10 training days after.

• 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.

  Baseline and 10 training days after.

• Change from baseline in Errors

  The number of times that a distractor stimulus appears and a response is given.

  Baseline and 10 training days after.

• 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.

  Baseline and 10 training days after.

• 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.

  Baseline and 10 training days after.

• 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.

  Baseline and 10 training days after.

• Change from baseline in SRT-R: Selective Reminding Test (Retrieval)

  This subtest of the BRB-N is a measure of memory retrieval capacity.

  Baseline and 10 training days after.

• Change from baseline in SRT-D: Selective Reminding Test (Delayed)

  This BRB-N subtest measures the delayed memory.

  Baseline and 10 training days after.

• Change from baseline in SPART: Spatial Recall Test

  A subtest of the BRB-N that measures spatial memory.

  Baseline and 10 training days after.

• Change from baseline in SPART-D: Spatial Recall Test (Delayed)

  This BRB-N subtest measures the spatial delayed memory.

  Baseline and 10 training days after.

• Change from baseline in SDMT: Symbol Digit Modalities Test

  A BRB-N subtest which measures information processing speed.

  Baseline and 10 training days after.

• Change from baseline in PASAT: Paced Auditory Serial Addition Task

  A BRB-N subtest which measures working memory.

  Baseline and 10 training days after.

• Change from baseline in Phonemic Fluency

  A language measure that assesses phonemic fluency.

  Baseline and 10 training days after.

• Change from baseline in Semantic Fluency

  A language measure that assesses semantic fluency.

  Baseline and 10 training days after.

• Change from baseline in Digit Span Forward

  A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.

  Baseline and 10 training days after.

• Change from baseline in Digit Span Backward

  A WAIS-III subtest that is a working memory measure.

  Baseline and 10 training days after.

• Change from baseline in Letters and Numbers

  A WAIS-III subtest that measures working memory.

  Baseline and 10 training days after.

Secondary Outcomes (5)

• Total Intracranial Volume (TIV)

  Baseline

• Brain Parenchymal Fraction (BPF)

  Baseline

• Lesion Volume in white matter tissue

  Baseline

• Cortical Lesions

  Baseline

• Cortical Thickness

  Baseline

Study Arms (2)

Working Memory Training in MS patients

EXPERIMENTAL

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

Behavioral: N-back Cognitive Training

Virtual Reality Training in MS patients

EXPERIMENTAL

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

Behavioral: Virtual Reality Motor and Cognitive Training

Interventions

N-back Cognitive Training BEHAVIORAL

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

Working Memory Training in MS patients

Virtual Reality Motor and Cognitive Training BEHAVIORAL

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

Virtual Reality Training in MS patients

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Multiple Sclerosis Diagnosis.

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I (ImagoBrain Research Group)

Castellon, Castellón, 12006, Spain

Location

Related Publications (6)

• 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.

  PMID: 25857687 BACKGROUND

• 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.

  PMID: 23828871 BACKGROUND

• 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.

  PMID: 25998261 BACKGROUND

• 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.

  PMID: 33964569 BACKGROUND

• 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.

  PMID: 29497559 BACKGROUND

• 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.

  PMID: 31139470 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cristina Forn

  Universitat Jaume I (Castellón, Spain)

  STUDY DIRECTOR

• Carla Sanchis

  Universitat Jaume I (Castellón, Spain)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 8, 2022
• Study Start: May 27, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)