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

October 11, 2024 updated by: IRCCS San Camillo, Venezia, Italy
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Over time, the literature has investigated the impairment of cognitive and psychological aspects in patients with vWN and MS, due to the fact that both conditions can affect normal cognitive functioning.

As far as VWN is concerned, most cases in humans are asymptomatic, while about 20% of infected subjects develop a disease defined as West Nile fever, characterized by symptoms such as fever, headache, muscle pain, possible skin rashes, and lymphadenopathy. Less than 1% of infected people develop a form of the virus defined as neuro-invasive, which can manifest itself through encephalitis, meningitis, and flaccid paralysis. From a cognitive point of view, following the development of the disease, the difficulties mainly reported by patients concern memory loss, the decrease in motor skills, the onset of depression, and the inability to carry out the activities of daily life as before the illness. Furthermore, deficits in attention and executive functions have been identified through the use of neuropsychological tests. The few studies present in the literature that have investigated the state of the cognitive system in patients with vWN often do not agree with the definition of a characteristic pattern. Therefore, a short pilot was carried out to evaluate cognitive deficits in patients with VWN outcomes currently hospitalized at the San Camillo IRCCS. From this pilot, it emerged that the main difficulties concern the attentional, executive, and visuospatial functions.

Even in MS, a chronic inflammatory, demyelinating, and degenerative disease of the central nervous system, cognitive deficits are often present, especially in patients with the Relapsing Remitting or Progressive form. Furthermore, more than 50% of patients experience depression. Cognitive impairment can affect specific functions or be severe and widespread, depending on the location of the brain lesions caused by the disease. In any case, the most affected cognitive functions are attention and information processing speed, short and long-term memory in its explicit subcomponent and prospective memory, executive functions, language, and visuospatial functions. However, as far as the latter are concerned, on the one hand, there are few studies that have investigated the visuospatial component in MS; on the other, these studies report inconsistent results, also due to the heterogeneity in the applied tests and in the terminology used to define these deficits. In these studies, in fact, the difference between visuospatial and visuo-perceptive deficits is not always clear, with a consequent, sometimes non-specific use of the relative tests.

Since the literature has not investigated the visuo-spatial deficit in vWN disease, further studies are needed to explore this disorder in patients with vWN infection outcomes and with MS for the role that this function plays in daily life. In fact, visuo-spatial skills allow the person to relate correctly with the surrounding environment, orienting himself and regulating his own behavior according to it. A deficit at this level compromises both personal and professional quality of life.

The present study arises from the need to investigate more fully the visuo-spatial component in patients with vWN infection outcomes and with MS and aims to evaluate the effectiveness of an innovative tool for its treatment.

The procedure to be used involves the use of prismatic lenses since their efficacy in the rehabilitation of visuo-spatial deficits has been demonstrated.

To this end, the treatment administered will be Mindlenses Professional, a cognitive rehabilitation tool that allows to combine the traditional prismatic adaptation procedure with serious games delivered through a tablet and aimed at rehabilitating other cognitive functions such as attention and executive functions. Several researchers have begun to use prismatic lenses as a non-invasive neuromodulation tool: the prismatic adaptation process would, in fact, allow to act on cortical excitability, in particular by increasing the excitability of the frontal and parietal cortices ipsilaterally to the lens-induced deviation.

Mindlenses Professional could, therefore, prove to be an effective tool for the rehabilitation of patients with outcomes of vWN infection and MS who also have deficits in visuospatial functions.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Venezia
      • Lido Di Venezia, Venezia, Italy, 30126
        • Recruiting
        • IRCCS San Camillo Hospital
        • Contact:
        • Contact:
          • Francesca Burgio, PhD
        • Contact:
          • Laura Danesin, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of psychiatric and/or concurrent neurological diseases
  • inability to provide informed consent,
  • impaired comprehension of oral instructions,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MindLenses Group
The group will undergo 10 sessions (2 weeks) of a treatment combining prismatic adaptation (PA) and serious games (SG) for cognitive training, using the Mindlenses Professional device. In each session, the PA procedure will be performed, followed by approximately 30 minutes of SG. SG will be focused on attention, executive functions and language.
Device: Mindlenses Professional
MindLenses professional's device combines the prismatic adaptation (PA) procedure with the administration of serious games (SG) for cognitive training using a tablet
Active Comparator: Control Group
The group will perform 2 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.
Behavioral: Conventional rehabilitation
Conventional rehabilition consists in computerized exercises focused on the main cognitive domains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of changes in cognitive performance after the treatment
Time Frame: At baseline and after 2 weeks (post-intervention)

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.
At baseline and after 2 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of changes in psychological aspects after the treatment
Time Frame: At baseline and after 2 weeks (post-intervention)

Psychological measures will be administered to investigate the presence of anxiety and depression in each patient.

Questionnaires will be scored based on published norms.
At baseline and after 2 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Camillo, Venezia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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