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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

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
        • IRCCS San Camillo Hospital

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: 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,

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
Active Comparator: 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.
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 -2
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of changes in cognitive and motor function after a treatment with Mindlenses professional
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging correlates of PA
Time Frame: At baseline
Structural (e.g., lesion mapping and/or voxel based morphometry) will be extracted by neuroimaging data acquired before and after treatment. Neuroimaging measures will be correlated with PA performances. PA will be performed using a tablet which automatically records poiniting displacement.
At baseline
Changes in brain plasticity after a treatment with Mindlenses professional
Time Frame: At baseline and after 2 weeks (post-intervention)
Brain plasticity will be assessed using the concentration of brain-derived neutrophic factor in plasma level. Patients' blood samples will be collected and will then be analysed using the ELISA kit for BDNF.
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

Collaborators

Restorative Neurotechnologies S.r.l.

Investigators

  • Principal Investigator: Francesca Burgio, PhD, IRCCS San Camillo Hospital

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)

October 5, 2021

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

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

  • 2021.12

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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