MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive

Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization

Running, not recruitingNot a drug-phase studyRelapsing and progressiveNCT04806568

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Cognitive Training

Given to everyone in the trial

  • Monitoring of daily activity

What it measured

Main measures

  • Change in current density strength of the cortical activity as measured via EEG

    3 months

    Physical functionNerve conduction tests

  • Change in cortical connectivity as measured via EEG

    3 months

    Nerve conduction tests

  • Changes in the graph theory indexes as measured via EEG

    3 months

    Nerve conduction tests

Other measures (22)

  • Change in audiovisual integration functionality

    3 months

  • Change in Mini Mental Status Examination (MMSE)

    3 months

    Thinking and memory

  • Change in Clock Drawing Test (CDT)

    3 months

    Thinking and memory

  • Change in Brief Visuospatial Memory Test (BVMT)

    3 months

    Thinking and memory

  • Change in Symbol Digit Modalities Test (SDMT)

    3 months

    Thinking and memory

  • Change in Verbal Fluency: Phonemic [ Chi-Sigma-Alpha]

    3 months

  • Change in Verbal Fluency: Semantic [Animals-Fruits-Objects]

    3 months

  • Change in Digit Span (For-Back-Seq) _WAIS-4GR

    3 months

    Thinking and memory

  • Change in Stroop Neuropsychological Test (SNST)

    3 months

    Thinking and memory

  • Change in Greek Accentuation Test (GAT)

    3 months

Who could take part

Relapsing and progressive · 18 to 65 · EDSS 0 to 6.5

Show the full criteria

Inclusion criteria

Inclusion Criteria for people with MS: * Male/female patients aged 18 to 65 years at screening * Diagnosis of MS according to the 2017 Revised McDonald criteria * Disability status at screening with an EDSS score of 0 to 6.5 * Relapsing MS and progressive MS as defined by Lublin * Neurologically stable within 1 month prior to screening * Patients receiving the same Disease Modifying Treatment (DMT) for at least 6 months Exclusion Criteria for people with MS: * Patients suspected of not being able or willing to cooperate or comply with study protocol requirements * Patients meeting criteria for other demyelinating diseases of the CNS * Patients with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Patients with any other significant CNS disease or serious psychiatric disorder which can interfere with the patient's ability to cooperate or comply with the study procedure * Patients unable or unwilling to undergo MRI scans and EEG Inclusion Criteria for Healthy Controls: • Normal hearing and normal or corrected-to-normal vision Exclusion Criteria for Healthy Controls: * Any diagnosed neurological, mental, developmental, or psychiatric disorder * Unrecovered neurological disorders (i.e., stroke, traumatic brain injury) * Unstable medication within the last 3 months * Intake of central nervous drugs (e.g., antidepressants) * Severe physical disorder * Concurrent participation in another relevant study * Patients unable or unwilling to undergo EEG measurements

Exclusion criteria

Not separately supplied in the registry.

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

About this trial

In the sponsor's words

This clinical study aims to identify MS related beneficial plasticity and by contrast maladaptive reorganization in combination with elements of daily functional status as a response to a cognitive training program

Papers

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History

    1. Started

      Dec 2020

    2. Main results due

      Dec 2025

    3. Finished

      Dec 2026

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