Sociocognitive rehabilitation via COGWEB platform combined with an emotional processing intervention.
Sociocognitive rehabilitation via COGWEB platform combined with an emotional processing intervention.: 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 summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Montreal Cognitive Assessment - MoCA (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Cognitive screening; Score 0-30 (0- worst outcome; 30- best outcome)
Ekman's Faces Test - EFT (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Social cognition and metacognition; Score 0-35 (0- worst outcome; 35- best outcome)
Reading the Mind in the Eyes Test - RMET (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Social cognition and metacognition; Score 0-36 (0- worst outcome; 36- best outcome)
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 Processing speed measures and metacognition; Score 0-110 adjusted for age and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
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 Verbal learning, memory and metacognition; Score 0-80 adjusted for age (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
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 Visual learning, memory and metacognition; Score 0-36 adjusted for age (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
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 Processing speed measures and metacognition; Score Score 0-60 adjusted for age, gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5)
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 Verbal learning, memory and metacognition; Score 0-70 adjusted for age, gender (0-male; 1-female) and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
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 Visual learning, memory and metacognition; Score 0-30 adjusted for age, gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
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 Language measures and metacognition; Score 0-67 adjusted for gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5).
Boston Naming Test - BNT (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Language measures: Score 0-30, calculated based on the number of items correctly named spontaneously.
d2 Test of Attention (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Measures processing speed, rule compliance, and quality of performance, allowing for an estimation of individual attention, according to several metrics. There is no specified cut-off.
Irregular Word Reading Test - TeLPI (neuropsychological test) — At baseline. Premorbid intelligence, ability to read irregularly spelled words ; there is no specified cut-off.
Stroop Test (neuropsychological test) — At baseline, follow-up 12 months, 18 months and follow-up 24 months Measures cognitive flexibility, processing speed, and executive function; Score varies according to speed and accuracy abilities. There is no specified cut-off.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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