Neurorehabilitation With Mindlenses in Stroke Patients

NCT07322614 | Completed

• 1 other identifier: RNT-CT#2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe the use of MindLenses, a rehabilitation device that integrates prism adaptation with serious game-based cognitive exercises, in individuals undergoing cognitive rehabilitation after stroke. The intervention consists of structured sessions combining visuomotor recalibration and gamified cognitive tasks designed to target domains such as attention, visuospatial processing, and executive functions. The study examines changes in cognitive performance across the intervention period and documents the characteristics of the training program. The objective is to provide a detailed description of the implementation of MindLenses in a clinical rehabilitation setting and to characterize the cognitive domains addressed through the combined prism-adaptation and game-based approach.

Conditions

Stroke

Keywords

Post-Stroke Cognitive Rehabilitation, Prism Adaptation, Serious Games, MindLenses, Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Global Cognitive Function Change Over Time

  Primary outcomes are changes in performance across a neuropsychological battery at baseline, post-treatment, 3- and 6-month follow-up. Measures include: Oxford Cognitive Screen (0-30), Raven's CPM (0-36), Digit Span (0-8), Corsi Block-Tapping (0-8), Rey 15-Word Test immediate (0-75) and delayed (0-15), Rey-Osterrieth Figure (0-36), Matrici Attentive (accuracy), Stroop interference (lower=better), Line Bisection deviation (lower=better), Bells Test (0-35), BADA Naming (accuracy), Phonemic and Semantic Fluency (correct words/60s), Copy of Drawings with (0-70) and without programming elements (0-12), VOSP (subtest scores), Buccofacial Apraxia Test (performance score). Higher scores indicate better performance unless noted.

  Baseline, immediately after completion of treatment, 3-month follow-up, and 6-month follow-up

Study Arms (2)

Experimental: MindLenses Cognitive Rehabilitation

EXPERIMENTAL

Participants in the experimental arm receive cognitive rehabilitation using the MindLenses device, a medical device that integrates prism adaptation with serious game-based cognitive training. Each session begins with a prism-adaptation phase, during which participants perform visuomotor tasks under an optically induced visual deviation to promote sensorimotor recalibration. Following this phase, participants complete a series of adaptive serious games designed to stimulate cognitive domains commonly affected after stroke, including attention, visuospatial abilities, processing speed, and executive functions. The games progressively adjust their difficulty based on user performance, ensuring individualized cognitive stimulation. Training sessions are delivered under the supervision of rehabilitation professionals following a standardized protocol, with frequency and duration aligned with the rehabilitation center's clinical practice.

Device: MindLenses Cognitive Training

Control: Standard Cognitive Rehabilitation

NO INTERVENTION

Participants in the control arm receive the standard cognitive rehabilitation program routinely provided in the clinical setting. This intervention consists of therapist-guided cognitive exercises targeting domains commonly affected after stroke, including attention, visuospatial abilities, processing speed, and executive functions. Sessions follow the center's established rehabilitation protocols and may include paper-and-pencil tasks, computerized cognitive exercises, visuospatial scanning activities, and structured problem-solving tasks. Training is administered by qualified rehabilitation professionals, with session frequency and duration consistent with usual clinical practice. No prism adaptation or gamified digital tasks are included in this arm.

Interventions

MindLenses Cognitive Training DEVICE

Cognitive rehabilitation delivered through the MindLenses medical device, which integrates prism adaptation with serious game-based cognitive exercises. Each session includes a visuomotor recalibration phase followed by adaptive game tasks targeting attention, visuospatial abilities, and executive functioning. Supervised by trained rehabilitation professionals according to a standardized protocol.

Also known as: Prism Adaptation + Serious Games

Experimental: MindLenses Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ischemic or hemorrhagic stroke, with a minimum interval of 30 days from the acute event
• Presence of cognitive deficits identified during the pre-treatment neuropsychological assessment
• Ability to understand and sign informed consent and willingness to participate in follow-up assessments
• Age ≥ 18 years

You may not qualify if:

• Upper limb motor impairments preventing the use of a tablet
• Severe visual deficits affecting stimulus perception
• Concurrent neurological or psychiatric disorders
• Substance abuse
• Diagnosis of dementia
• Severe Wernicke's aphasia
• Age \> 80 years

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Irccs Fondazione Santa Lucia

Roma, RM, 00179, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: March 19, 2021
• Primary Completion: February 10, 2023
• Study Completion: June 1, 2023
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

IT (1)