Investigating Neurocognitive, Motor and Biological Effects of MindLenses Professional in Neurological Diseases

NCT ID: NCT05826626

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2024-09-30

Brief Summary

This study aims to explore the effects of the treatment with MindLenses Professional device on cognitive and motor performances,as 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 treatment's 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 S.r.l. 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 patient's cognitive functioning and allow the clinician to identify patient's difficulties. From the perfoemances at these tasks, the clinician can schedule a rehabilitation program tailored on the patient's 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.

Conditions

Stroke; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental 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.

Group Type: EXPERIMENTAL

MindLenses Professional

Intervention Type: DEVICE

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

Control Group -1

The group will undergo 10 sessions (2 weeks) of a treatment using the serious games (SG) for cognitive training provided by the Mindlenses Professional device. SG will be focused on attention, executive functions and language.

Group Type: ACTIVE_COMPARATOR

MindLenses Professional

Intervention Type: DEVICE

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

Control Group -2

The group will perform 2 weeks of the standard cognitive training offered by IRCCS San Camillo Hospital.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: DEVICE

Conventional rehabilitation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• diagnosis of: Mild Cognitive Impairment, and stroke
• 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restorative Neurotechnologies S.r.l.

UNKNOWN

Sponsor Role: collaborator

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesca Burgio, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Camillo Hospital

Locations

IRCCS San Camillo Hospital

Lido, Venezia, Italy

Countries

Italy

References

Bonaventura RE, Giustino V, Chiaramonte G, Giustiniani A, Smirni D, Battaglia G, Messina G, Oliveri M. Investigating prismatic adaptation effects in handgrip strength and in plantar pressure in healthy subjects. Gait Posture. 2020 Feb;76:264-269. doi: 10.1016/j.gaitpost.2019.12.022. Epub 2019 Dec 23.

Reference Type: BACKGROUND

PMID: 31881480 (View on PubMed)

Bracco M, Mangano GR, Turriziani P, Smirni D, Oliveri M. Combining tDCS with prismatic adaptation for non-invasive neuromodulation of the motor cortex. Neuropsychologia. 2017 Jul 1;101:30-38. doi: 10.1016/j.neuropsychologia.2017.05.006. Epub 2017 May 6.

Reference Type: BACKGROUND

PMID: 28487249 (View on PubMed)

Bracco M, Veniero D, Oliveri M, Thut G. Prismatic Adaptation Modulates Oscillatory EEG Correlates of Motor Preparation but Not Visual Attention in Healthy Participants. J Neurosci. 2018 Jan 31;38(5):1189-1201. doi: 10.1523/JNEUROSCI.1422-17.2017. Epub 2017 Dec 18.

Reference Type: BACKGROUND

PMID: 29255004 (View on PubMed)

Cubelli R. Definition: Spatial neglect. Cortex. 2017 Jul;92:320-321. doi: 10.1016/j.cortex.2017.03.021. Epub 2017 Apr 7. No abstract available.

Reference Type: BACKGROUND

PMID: 28454716 (View on PubMed)

Farne A, Rossetti Y, Toniolo S, Ladavas E. Ameliorating neglect with prism adaptation: visuo-manual and visuo-verbal measures. Neuropsychologia. 2002;40(7):718-29. doi: 10.1016/s0028-3932(01)00186-5.

Reference Type: BACKGROUND

PMID: 11900724 (View on PubMed)

Frassinetti F, Angeli V, Meneghello F, Avanzi S, Ladavas E. Long-lasting amelioration of visuospatial neglect by prism adaptation. Brain. 2002 Mar;125(Pt 3):608-23. doi: 10.1093/brain/awf056.

Reference Type: BACKGROUND

PMID: 11872617 (View on PubMed)

Gammeri R, Iacono C, Ricci R, Salatino A. Unilateral Spatial Neglect After Stroke: Current Insights. Neuropsychiatr Dis Treat. 2020 Jan 10;16:131-152. doi: 10.2147/NDT.S171461. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32021206 (View on PubMed)

Magnani B, Caltagirone C, Oliveri M. Prismatic adaptation as a novel tool to directionally modulate motor cortex excitability: evidence from paired-pulse TMS. Brain Stimul. 2014 Jul-Aug;7(4):573-9. doi: 10.1016/j.brs.2014.03.005. Epub 2014 Apr 13.

Reference Type: BACKGROUND

PMID: 24934876 (View on PubMed)

Rode G, Rossetti Y, Boisson D. Prism adaptation improves representational neglect. Neuropsychologia. 2001;39(11):1250-4. doi: 10.1016/s0028-3932(01)00064-1.

Reference Type: BACKGROUND

PMID: 11527562 (View on PubMed)

Rossetti Y, Rode G, Pisella L, Farne A, Li L, Boisson D, Perenin MT. Prism adaptation to a rightward optical deviation rehabilitates left hemispatial neglect. Nature. 1998 Sep 10;395(6698):166-9. doi: 10.1038/25988.

Reference Type: BACKGROUND

PMID: 9744273 (View on PubMed)

Serino A, Bonifazi S, Pierfederici L, Ladavas E. Neglect treatment by prism adaptation: what recovers and for how long. Neuropsychol Rehabil. 2007 Dec;17(6):657-87. doi: 10.1080/09602010601052006.

Reference Type: BACKGROUND

PMID: 17852762 (View on PubMed)

Wilf M, Serino A, Clarke S, Crottaz-Herbette S. Prism adaptation enhances decoupling between the default mode network and the attentional networks. Neuroimage. 2019 Oct 15;200:210-220. doi: 10.1016/j.neuroimage.2019.06.050. Epub 2019 Jun 22.

Reference Type: BACKGROUND

PMID: 31233909 (View on PubMed)

Other Identifiers

2021.12

Identifier Type: -

Identifier Source: org_study_id