Investigating Visuo-spatial Abilities and Psychological Effects in West Nile and Multiple Sclerosis Patients with a Focus on a Possible Rehabilitation Protocol

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorIRCCS San Camillo, Venezia, Italy

About this trial

The study aims to investigate visuospatial abilities and psychological outcomes in patients with multiple scleroris (MS) and patients with West Nile virus infection (vWN). Patients will undergo a specific neuropsychological and psychological evaluation. Afterwards, patients will receive 10 sessions of cognitive training integrating digital exercises and prismatic lenses. At the end of the treatment, patients will be re-evaluated to explore for potential changes in the cognitive and psychological profile.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of: Multiple Scleroris OR vWN infection ascertained by laboratory analysis and received no later than twelve months prior to the date of hospitalization

preserved use of at least one hand

normal or corrected to normal vision

Disqualifiers

history of psychiatric and/or concurrent neurological diseases

inability to provide informed consent,

impaired comprehension of oral instructions,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindlenses Professional

    Device

    MindLenses professional's device combines the prismatic adaptation (PA) procedure with the administration of serious games (SG) for cognitive training using a tablet

  • Conventional rehabilitation

    Behavioral

    Conventional rehabilition consists in computerized exercises focused on the main cognitive domains

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MindLenses GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Measure of changes in cognitive performance after the treatment

Cognitive performances will be assessed by a full neuropsychological battery encompassing the main cognitive domain, such as memory, attention, executive function, language, visuospatial abilities. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test and scale will be converted in z-scores based on each test/scale normative data. Z-scores will be averaged to calculate composite scores specific for each cognitive domain and for motor functioning. In detail, the composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.

Time frame
At baseline and after 2 weeks (post-intervention)

Secondary outcomes

1

Measure of changes in psychological aspects after the treatment

Psychological measures will be administered to investigate the presence of anxiety and depression in each patient. Questionnaires will be scored based on published norms.

Time frame
At baseline and after 2 weeks (post-intervention)

Other outcomes

Sponsors and contacts

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