MSFrontier

REACT-MS

Sociocognitive Intervention and Rehabilitation Program in Multiple Sclerosis: Implications for Cognitive Reserve and Metacognition
Not yet recruitingNot a drug-phase studyRelapsing MSNCT07734675

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Sociocognitive rehabilitation via COGWEB platform combined with an emotional processing intervention.

What it measured

Main measures

  • Montreal Cognitive Assessment - MoCA (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Ekman's Faces Test - EFT (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Reading the Mind in the Eyes Test - RMET (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Symbol Digit Modalities Test - SDMT (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • California Verbal Learning Test - CVLT-II (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Brief Visuospatial Memory Test - BVMT-R (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Paced Auditory Serial Addition Test - PASAT (part of BRBN-T: Brief repeatable battery of neuropsychological tests)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Selective Reminding Test - SRT (part of BRBN-T: Brief repeatable battery of neuropsychological tests)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • 10/36 Spatial Recall Test - SPART (part of BRBN-T: Brief repeatable battery of neuropsychological tests)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Word List Generation Test - WLG (part of BRBN-T: Brief repeatable battery of neuropsychological tests)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Boston Naming Test - BNT (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

  • d2 Test of Attention (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

  • Irregular Word Reading Test - TeLPI (neuropsychological test)

    At baseline.

  • Stroop Test (neuropsychological test)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Thinking and memory

Other measures (13)

  • Modified Fatigue Impact Scale - MFIS (PROM: Patient Reported Outcome Measure)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    FatigueQuality of life (reported by participants)

  • Cognitive Reserve Index Questionnaire - CRIq

    At baseline

    Thinking and memory

  • Hospital Anxiety and Depression Scale - HADS (PROM: Patient Reported Outcome Measure)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Mood and sleepQuality of life (reported by participants)

  • World Health Organization Quality of Life short-form - WHOQOL-Bref (PROM: Patient Reported Outcome Measure)

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Quality of life (reported by participants)

  • Neurofilament Light chain (NfL): pg/mL

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    RelapsesBlood or spinal fluid markers

  • Glial Fibrillary Acidic Protein (GFAP): pg/mL

    At baseline, follow-up 12 months, 18 months and follow-up 24 months

    Blood or spinal fluid markers

  • Number of T2 lesions in brain MRI

    At baseline, follow-up 12 months and follow-up 24 months

    MRI lesions

  • Status of MRI T2 lesions

    At baseline, 12 months and 24 months.

    MRI lesions

  • MRI lesion load (mm3)

    At baseline, 12 months, 18 months and 24 months.

    MRI lesions

  • MRI- affected brain region (cerebellum)

    At baseline, 12 months and 24 months.

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: * Patients diagnosed with Multiple Sclerosis; * Complete clinical assessment (neuroimaging biomarkers-MRI, neuropsychological and biochemical biomarkers-cerebrospinal fluid and serum) * Age between 18-55 years; * Portuguese native language; * Fulfil the criteria for cognitive impairment as defined by either the BICAMS- with one or more test scores below the 5th percentile relative to the control group - and/or the BRBN-T - with at least two test scores below the 5th percentile relative to the control group; * Present deficits in social cognition. Exclusion Criteria: * MoCA score \<23; * History of traumatic brain injury resulting in loss of consciousness; * Severe language, visual, or auditory impairments; * Current or past use of antipsychotic medication; * Alcohol, drug, or other substance abuse; * Medical conditions that contraindicate MRI.

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

Contact details on the registry

About this trial

In the sponsor's words

Multiple Sclerosis (MS) is a chronic autoimmune disease of the central nervous system, involving inflammation, demyelination, and neurodegeneration. It is the most common non-traumatic disabling disease affecting young adults. MS is characterized by its heterogeneity and unpredictable course, which make both evaluation and treatment complex. Patients may present with motor, sensory, cognitive, and neuropsychiatric symptoms, all of which have a significant impact on quality of life. With regard to cognition, the impact of cognitive impairment in MS remains underestimated. However, it is observed in approximately 40-65% of patients and may be present at all stages of the disease, including the earliest ones (patients with low levels of disability and Clinically Isolated Syndromes - CIS). Notably, cognitive alterations appear to precede structural abnormalities on magnetic resonance imaging (MRI), representing a potential marker of disease activity. Therefore, early diagnosis and characterization of MS-related cognitive impairment are essential, followed by the implementation of patient-tailored cognitive rehabilitation programs, which have recently been shown to exert long-term effects persisting beyond the treatment period. The project aims to conduct a single-center, randomized, pragmatic, prospective clinical trial with blinded outcome assessment. Its primary objective is to evaluate the efficacy of an innovative sociocognitive rehabilitation program in patients diagnosed with multiple sclerosis. In addition, the study seeks to characterize cognitive phenotypes in MS, investigate the role of cognitive reserve and metacognition in the effectiveness of the intervention, and correlate neuropsychological findings with other disease biomarkers, with the ultimate goal of proposing a predictive model of disease progression.

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History

    1. Started

      Sept 2026

    2. Main results due

      Jun 2027

    3. Finished

      Dec 2027

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