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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intracranial Volume (TIV) | A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence. | Baseline |
| Brain Parenchymal Fraction (BPF) | MRI sequence: structural T1-weighted MPRAGE sequence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Forn | Universitat Jaume I (Castellón, Spain) | Study Director |
| Carla Sanchis | Universitat Jaume I (Castellón, Spain) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Jaume I (ImagoBrain Research Group) | Castellon | Castellón | 12006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25857687 | Background | 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. | |
| 23828871 |
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Not foreseen due to the ethics committee's privacy policy on the protection of personal data. However, upon request, radiological data could be shared.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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) |
|
| 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. |
| Baseline |
| Lesion Volume in white matter tissue | A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence | Baseline |
| Cortical Lesions | Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR). | Baseline |
| Cortical Thickness | Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence. | Baseline |
| 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. |
| 25998261 | 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. |
| 33964569 | 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. |
| 29497559 | 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. |
| 31139470 | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |