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Completed

NCT Number: NCT05270239

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Jaume I (ImagoBrain Research Group)

Castellon, Castellón, 12006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple Sclerosis Diagnosis.

Exclusion criteria

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

Treatment and study plan

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).

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)

Primary outcomes

  1. Change from baseline in Correct Responses

    Time frame: Baseline and 10 training days after.

    Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)

  2. Change from baseline in Reaction Time

    Time frame: 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.

  3. Change from baseline in Omissions

    Time frame: 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.

  4. Change from baseline in Errors

    Time frame: Baseline and 10 training days after.

    The number of times that a distractor stimulus appears and a response is given.

  5. Change from baseline in Functional Connectivity in resting state

    Time frame: 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.

  6. Change from baseline in Functional Connectivity in task performance

    Time frame: 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.

  7. Change from baseline in SRT-S: Selective Reminding Test (Storing)

    Time frame: 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.

  8. Change from baseline in SRT-R: Selective Reminding Test (Retrieval)

    Time frame: Baseline and 10 training days after.

    This subtest of the BRB-N is a measure of memory retrieval capacity.

  9. Change from baseline in SRT-D: Selective Reminding Test (Delayed)

    Time frame: Baseline and 10 training days after.

    This BRB-N subtest measures the delayed memory.

  10. Change from baseline in SPART: Spatial Recall Test

    Time frame: Baseline and 10 training days after.

    A subtest of the BRB-N that measures spatial memory.

  11. Change from baseline in SPART-D: Spatial Recall Test (Delayed)

    Time frame: Baseline and 10 training days after.

    This BRB-N subtest measures the spatial delayed memory.

  12. Change from baseline in SDMT: Symbol Digit Modalities Test

    Time frame: Baseline and 10 training days after.

    A BRB-N subtest which measures information processing speed.

  13. Change from baseline in PASAT: Paced Auditory Serial Addition Task

    Time frame: Baseline and 10 training days after.

    A BRB-N subtest which measures working memory.

  14. Change from baseline in Phonemic Fluency

    Time frame: Baseline and 10 training days after.

    A language measure that assesses phonemic fluency.

  15. Change from baseline in Semantic Fluency

    Time frame: Baseline and 10 training days after.

    A language measure that assesses semantic fluency.

  16. Change from baseline in Digit Span Forward

    Time frame: Baseline and 10 training days after.

    A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.

  17. Change from baseline in Digit Span Backward

    Time frame: Baseline and 10 training days after.

    A WAIS-III subtest that is a working memory measure.

  18. Change from baseline in Letters and Numbers

    Time frame: Baseline and 10 training days after.

    A WAIS-III subtest that measures working memory.

Secondary outcomes

  1. Total Intracranial Volume (TIV)

    Time frame: Baseline

    A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.

  2. Brain Parenchymal Fraction (BPF)

    Time frame: Baseline

    MRI sequence: structural T1-weighted MPRAGE sequence.

  3. Lesion Volume in white matter tissue

    Time frame: Baseline

    A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence

  4. Cortical Lesions

    Time frame: Baseline

    Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).

  5. Cortical Thickness

    Time frame: Baseline

    Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

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

Acronym: NeuroRehEM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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