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

Universitat Jaume I

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: N-back Cognitive Training; Behavioral: Virtual Reality Motor and Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05270239

PID2019-106793RB-I00

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multiple Sclerosis Diagnosis.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Working Memory Training in MS patients

Experimental group

Description:

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

Treatment:

Behavioral: N-back Cognitive Training

Virtual Reality Training in MS patients

Experimental group

Description:

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

Treatment:

Behavioral: Virtual Reality Motor and Cognitive Training