Sociocognitive Intervention and Rehabilitation Program in Multiple Sclerosis

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Conditions studied: Multiple Sclerosis

In brief

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 facts

Study ID

NCT07734675

Run by

Sonia Batista

People needed

130

Starts

2026-09-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Health Unit of Coimbra — Coimbra, Coimbra District, Portugal
• Unidade Local de Saude de Coimbra — Coimbra, Coimbra District, Portugal

Full record on ClinicalTrials.gov

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