Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05826626
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2023-03-16
Brief Title:
Investigating Neurocognitive Motor and Biological Effects of MindLenses Professional in Neurological Diseases
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
Investigating Neurocognitive Motor and Biological Effects of MindLenses Professional in Neurological Diseases
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MindLensesN
Brief Summary:
This study aims to explore the effects of the treatment with MindLenses Professional device on cognitive and motor performancesas well as on the levels of a neurotrophic factor implied in brain plasticity that is the brain derived neurotrophic factor BDNF in neurological patients A further aim of the study is to evaluate if the treatments efficacy could depend on specific characteristics of brain alteration lesion vs atrophy The treatment combines prismatic adaptation with serious games for cognitive training for a total of 10 sessions 30 patients with stroke and 30 patients with Mild Cognitive Impairment will be enrolled
Detailed Description:
Prismatic lenses refers to a device that allow a controlled deviation of the visual field Prismatic lenses are commonly used in the treatment of stroke patients with neglect symptoms Neglect is a neuropsychological disorder characterised by an asymmetric processing of bodily and sensory information in which patients fail to attend to stimuli in the contralesional space Prismatic lenses are considered as a bottom-up approach in the rehabilitation of neglect inducing a temporary automatic shift of the attention towards the neglected space While wearing goggles with prismatic lenses patients are asked to perform a pointing task requiring the reorganization of visuo-motor coordinates to point to the target correctly During the initial phase of the pointing task patients typically misreach the target in the direction of the visual displacement direct effect After a few trials normal accuracy is restored After removing the prisms subjects typically misreach the target in the direction opposite to that of the original deviation This phenomenon is known as after effect AE The whole process of sensori-motor adaptation is called prism adaptation PA Some studies estimates that a single session of PA can mitigate neglect symptoms for almost 1 hour and a treatment with PA for 2 weeks can ameliorate symptoms for 6 months Recently prismatic lenses have been used also in the healthy population as a tool to induce non-invasive neuromodulation of brain networks Indeed PA is thought to increase cortical excitability of frontal and parietal regions ipsilateral to the induced deviation PA effects been studied using electrophysiological and neuroanatomical techniques In the first case Bracco and colleagues 2018 found a modulation of EEG activity implied in motor preparation during PA In the second case Wilf and colleagues 2019 observed a more efficient switch between default mode network and attentive network following PA Moreover a recent study reported that PA could affect also motor outcomes such as plantar pressure and handgrip strength
Recently Restorative Neurotechnologies Srl created Mindlenses Professional a new digital tool that combines PA with serious games for cognitive rehabilitation Both PA and seirous games are performed using a tablet Concerning PA administration black squares are presented in the centre on the left or on the right of the screen Patients are required to touch the black square with rapid and precise movements Mindlenses combines the neuromodulatory potential of PA to increase the rehabilitative outcomes of the digital exercises Preliminary results showed that the combination of these two techniques can ameliorate attention and executive function
Mindlenses professional includes 12 assessment tasks and 7 rehabilitation exercises which encompass 6 cognitive domain attention visual search memory learning working memory and language The 12 assessment tasks do not replace a full neurpsyhcological evaluation but can be informative on the patients cognitive functioning and allow the clinician to identify patients difficulties From the perfoemances at these tasks the clinician can schedule a rehabilitation program tailored on the patients need The treatment consists in 10 sessions in which the patient performs both PA and serious games
The aim of this project is to validate Mindlenses Professional in patients with stroke or with mild cognitive impairment MCI
Mindlenses efficacy will be evaluated in terms of changes in cognitive and motor performance before and after the treatment compared to a treatment using only serious games and to conventional cognitive rehabilitation Moreover patients neuroimaging data will be acquired to explore whether vascular lesions or atrophy in specific brain regions could affect the PA performance and the efficacy of the treatment Lastly changes in brain plasticity assessed as plasma levels of the brain derived neurotrophic factor BDNF before and after the treatment will be investigated
Recently Restorative Neurotechnologies Srl created Mindlenses Professional a new digital tool that combines PA with serious games for cognitive rehabilitation Both PA and seirous games are performed using a tablet Concerning PA administration black squares are presented in the centre on the left or on the right of the screen Patients are required to touch the black square with rapid and precise movements Mindlenses combines the neuromodulatory potential of PA to increase the rehabilitative outcomes of the digital exercises Preliminary results showed that the combination of these two techniques can ameliorate attention and executive function
Mindlenses professional includes 12 assessment tasks and 7 rehabilitation exercises which encompass 6 cognitive domain attention visual search memory learning working memory and language The 12 assessment tasks do not replace a full neurpsyhcological evaluation but can be informative on the patients cognitive functioning and allow the clinician to identify patients difficulties From the perfoemances at these tasks the clinician can schedule a rehabilitation program tailored on the patients need The treatment consists in 10 sessions in which the patient performs both PA and serious games
The aim of this project is to validate Mindlenses Professional in patients with stroke or with mild cognitive impairment MCI
Mindlenses efficacy will be evaluated in terms of changes in cognitive and motor performance before and after the treatment compared to a treatment using only serious games and to conventional cognitive rehabilitation Moreover patients neuroimaging data will be acquired to explore whether vascular lesions or atrophy in specific brain regions could affect the PA performance and the efficacy of the treatment Lastly changes in brain plasticity assessed as plasma levels of the brain derived neurotrophic factor BDNF before and after the treatment will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None