Sociocognitive Intervention and Rehabilitation Program in Multiple Sclerosis

Sponsor
Sonia Batista
Study ID
NCT07734675
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Sociocognitive rehabilitation via COGWEB platform combined with an emotional processing intervention. — BEHAVIORAL
    Participants in the study group will subjected weekly sessions of sociocognitive rehabilitation using the COGWEB platform, combined with an emotional processing intervention, aimed at enhancing cognitive abilities and facial expression recognition. Most sessions will be conducted online in a home-based setting, with only one in-person session required every three months in a hospital environment. The dual intervention will be administered over a 12-month period.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Rehabilitation Group
  • No Intervention: Control Group

Primary Outcome Measure

Montreal Cognitive Assessment - MoCA (neuropsychological test) [ Time Frame: At baseline, follow-up 12 months, 18 months and follow-up 24 months ]

Central Contacts

  • Clinical Trials Unit do Centro Académico Clínico de Coimbra CTU CTU-CACC
    239400400
    [email protected]
  • Clinical Trials Unit - Coimbra Academic Clinical Center CTU CTU-CACC
    +351 239 400 400
    [email protected]

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