Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: N-back Cognitive TrainingBehavioral: Virtual Reality Motor and Cognitive Training
- Registration Number
- NCT05270239
- Lead Sponsor
- Universitat Jaume I
- 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, innovaciĆ³n y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- Multiple Sclerosis Diagnosis.
- Other neurological pathologies comorbidity.
- Magnetic resonance imaging incompatibilities.
- Motor impairment degree that impede the task performance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Working Memory Training in MS patients N-back Cognitive Training 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 Virtual Reality Motor and Cognitive Training This group of patients will perform a Virtual Reality "Ball Task" training. This task contains 6 trials of increasing difficulty.
- Primary Outcome Measures
Name Time Method Change from baseline in Omissions Baseline and 10 training days after. In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Change from baseline in Functional Connectivity in resting state Baseline and 10 training days after. 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 Letters and Numbers Baseline and 10 training days after. A WAIS-III subtest that measures working memory.
Change from baseline in SRT-S: Selective Reminding Test (Storing) Baseline and 10 training days after. 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) Baseline and 10 training days after. This subtest of the BRB-N is a measure of memory retrieval capacity.
Change from baseline in SDMT: Symbol Digit Modalities Test Baseline and 10 training days after. A BRB-N subtest which measures information processing speed.
Change from baseline in PASAT: Paced Auditory Serial Addition Task Baseline and 10 training days after. A BRB-N subtest which measures working memory.
Change from baseline in Digit Span Backward Baseline and 10 training days after. A WAIS-III subtest that is a working memory measure.
Change from baseline in Correct Responses Baseline and 10 training days after. Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Change from baseline in Reaction Time Baseline and 10 training days after. 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 Errors Baseline and 10 training days after. The number of times that a distractor stimulus appears and a response is given.
Change from baseline in Functional Connectivity in task performance Baseline and 10 training days after. 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 SPART-D: Spatial Recall Test (Delayed) Baseline and 10 training days after. This BRB-N subtest measures the spatial delayed memory.
Change from baseline in Semantic Fluency Baseline and 10 training days after. A language measure that assesses semantic fluency.
Change from baseline in SRT-D: Selective Reminding Test (Delayed) Baseline and 10 training days after. This BRB-N subtest measures the delayed memory.
Change from baseline in SPART: Spatial Recall Test Baseline and 10 training days after. A subtest of the BRB-N that measures spatial memory.
Change from baseline in Phonemic Fluency Baseline and 10 training days after. A language measure that assesses phonemic fluency.
Change from baseline in Digit Span Forward Baseline and 10 training days after. A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
- Secondary Outcome Measures
Name Time Method Brain Parenchymal Fraction (BPF) Baseline MRI sequence: structural T1-weighted MPRAGE sequence.
Cortical Lesions Baseline Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).
Lesion Volume in white matter tissue Baseline A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence
Total Intracranial Volume (TIV) Baseline A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.
Cortical Thickness Baseline Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.
Trial Locations
- Locations (1)
Universitat Jaume I (ImagoBrain Research Group)
šŖšøCastellĆ³n De La Plana, CastellĆ³n, Spain