Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640660
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-07
Brief Title:
Investigating Visuo-spatial Abilities and Psychological Effects in West Nile and Multiple Sclerosis Patients with a Focus on a Possible Rehabilitation Protocol
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating Visuo-spatial Abilities and Psychological Effects in West Nile and Multiple Sclerosis Patients with a Focus on a Possible Rehabilitation Protocol
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Visuomind
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None