Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.

CompletedNot a drug-phase studyMS (type not specified)NCT05270239

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • N-back Cognitive Training
  • Virtual Reality Motor and Cognitive Training

What it measured

Main measures

  • Change from baseline in Correct Responses

    Baseline and 10 training days after.

  • Change from baseline in Reaction Time

    Baseline and 10 training days after.

  • Change from baseline in Omissions

    Baseline and 10 training days after.

  • Change from baseline in Errors

    Baseline and 10 training days after.

  • Change from baseline in Functional Connectivity in resting state

    Baseline and 10 training days after.

    MRI lesionsNerve conduction tests
  • Change from baseline in Functional Connectivity in task performance

    Baseline and 10 training days after.

    MRI lesionsNerve conduction tests
  • Change from baseline in SRT-S: Selective Reminding Test (Storing)

    Baseline and 10 training days after.

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

    Baseline and 10 training days after.

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

    Baseline and 10 training days after.

    Thinking and memory
  • Change from baseline in SPART: Spatial Recall Test

    Baseline and 10 training days after.

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

    Baseline and 10 training days after.

    Thinking and memory
  • Change from baseline in SDMT: Symbol Digit Modalities Test

    Baseline and 10 training days after.

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

    Baseline and 10 training days after.

    Thinking and memory
  • Change from baseline in Phonemic Fluency

    Baseline and 10 training days after.

  • Change from baseline in Semantic Fluency

    Baseline and 10 training days after.

  • Change from baseline in Digit Span Forward

    Baseline and 10 training days after.

    Thinking and memory
  • Change from baseline in Digit Span Backward

    Baseline and 10 training days after.

    Thinking and memory
  • Change from baseline in Letters and Numbers

    Baseline and 10 training days after.

    Thinking and memory

Other measures (5)

  • Total Intracranial Volume (TIV)

    Baseline

    MRI lesionsBrain volume loss
  • Brain Parenchymal Fraction (BPF)

    Baseline

    MRI lesionsBrain volume loss
  • Lesion Volume in white matter tissue

    Baseline

    MRI lesions
  • Cortical Lesions

    Baseline

    MRI lesions
  • Cortical Thickness

    Baseline

    MRI lesions

Who could take part

MS (type not specified) · 19 to 60

Show the full criteria

Inclusion criteria

* Multiple Sclerosis Diagnosis.

Exclusion criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      May 2022

    2. Main results due

      Jul 2023

    3. Finished

      Jul 2023

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