Clinical trial NCT05270239: Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).
Official title: Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Magnetic Resonance Imaging
Neuroplasticity
Cognitive Impairment
Virtual Reality
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


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.

Primary outcomes:
measure: Change from baseline in Correct Responses
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Reaction Time
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Omissions
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Errors
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Functional Connectivity in resting state
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Functional Connectivity in task performance
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SRT-S: Selective Reminding Test (Storing)
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SRT-D: Selective Reminding Test (Delayed)
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SPART: Spatial Recall Test
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SPART-D: Spatial Recall Test (Delayed)
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in SDMT: Symbol Digit Modalities Test
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in PASAT: Paced Auditory Serial Addition Task
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Phonemic Fluency
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Semantic Fluency
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Digit Span Forward
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Digit Span Backward
timeFrame: Baseline and 10 training days after.
measure: Change from baseline in Letters and Numbers
timeFrame: Baseline and 10 training days after.
Secondary outcomes:
measure: Total Intracranial Volume (TIV)
timeFrame: Baseline
measure: Brain Parenchymal Fraction (BPF)
timeFrame: Baseline
measure: Lesion Volume in white matter tissue
timeFrame: Baseline
measure: Cortical Lesions
timeFrame: Baseline
measure: Cortical Thickness
timeFrame: Baseline
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I (ImagoBrain Research Group)
state: Castellón
Study officials:
affiliation: Universitat Jaume I (Castellón, Spain)
name: Cristina Forn
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I (Castellón, Spain)
name: Carla Sanchis
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.