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

NCT05826626 | Completed DMC

• 1 other identifier: 2021.12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Mild Cognitive Impairment

Keywords

prism adaptation; cognitive training; neurological patients; neuropsychology

Outcome Measures

Primary Outcomes (1)

• Measure of changes in cognitive and motor function after a treatment with Mindlenses professional

  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. Motor function will be assessed using functional scales such as FIM and FAM. 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, motor functioning.

  At baseline and after 2 weeks (post-intervention)

Secondary Outcomes (2)

• Neuroimaging correlates of PA

  At baseline

• Changes in brain plasticity after a treatment with Mindlenses professional

  At baseline and after 2 weeks (post-intervention)

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Control Group -1

ACTIVE COMPARATOR

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.

Device: MindLenses Professional

Control Group -2

ACTIVE COMPARATOR

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

Behavioral: Conventional rehabilitation

Interventions

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

Control Group -1; Experimental Group

Conventional rehabilitation BEHAVIORAL

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

Control Group -2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of: Mild Cognitive Impairment, and stroke
• preserved use of at least one hand,
• normal or corrected to normal vision

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Restorative Neurotechnologies S.r.l.: collaborator

Study Sites (1)

IRCCS San Camillo Hospital

Lido, Venezia, 30126, Italy

Location

Related Publications (12)

• 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.

  PMID: 31881480 BACKGROUND

• 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.

  PMID: 28487249 BACKGROUND

• 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.

  PMID: 29255004 BACKGROUND

• 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.

  PMID: 28454716 BACKGROUND

• 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.

  PMID: 11900724 BACKGROUND

• 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.

  PMID: 11872617 BACKGROUND

• 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.

  PMID: 32021206 BACKGROUND

• 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.

  PMID: 24934876 BACKGROUND

• 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.

  PMID: 11527562 BACKGROUND

• 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.

  PMID: 9744273 BACKGROUND

• 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.

  PMID: 17852762 BACKGROUND

• 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.

  PMID: 31233909 BACKGROUND

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Francesca Burgio, PhD

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stroke and MCI patients will be recruited in the IRCCS San Camillo Hospital. The selection will be based on diagnosis made by an expert neurologist and on a neuropsychological evaluation. Enrolled patients will be randomized in three groups and by using a block randomization sequence (Random.org), to receive MindLenses combines treatment (prism adaptation+serious games(PA+SG), n=20), treatment with MindLenses's serious games (SG without prism adaptation, n=20), or conventional treatment (CT, n=20). The PA+SG and the SG groups will perform 5 daily sessions, 30 min each, per 2 weeks. The CT group will undergo the standard cognitive training offered by the Hospital for the same duration as the other two groups.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 24, 2023
• Study Start: October 5, 2021
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)