Neurorehabilitation With Mindlenses in Stroke Patients

This clinical investigation aims to evaluate the safety and effectiveness of the MindLenses system, a medical device integrating prism adaptation with serious game-based cognitive training for post-stroke rehabilitation. The study includes two groups: an experimental group receiving the MindLenses intervention and a control group receiving standard cognitive and motor rehabilitation. The investigation focuses on device safety, changes in cognitive and motor performance, and measures related to usability and procedural feasibility.

Intervention Description:

The MindLenses intervention consists of a structured treatment session combining a prism-adaptation phase with adaptive serious games. During prism adaptation, participants perform visuomotor tasks under optically deviated vision to promote sensorimotor recalibration. The subsequent serious game phase provides exercises targeting attention, visuospatial abilities, executive functions, memory, and processing speed, with automatic difficulty adjustment based on performance. Sessions are delivered under therapist supervision and follow a standardized protocol.

Participants in the control group undergo standard clinical cognitive and motor rehabilitation, including paper-and-pencil tasks, visuospatial scanning, problem-solving activities, and conventional motor therapy. No prism-adaptation or serious-game elements are used in the control arm.

Assessments and Follow-Up:

All participants complete a comprehensive neuropsychological battery assessing memory, attention, language, executive functions, praxis and constructional abilities, intelligence, and visuospatial and visuoperceptual functions. Motor performance is evaluated using the Ashworth Scale (spasticity) and the Motor Assessment Scale (daily motor function).

Assessments are conducted at four time points:

Baseline (pre-treatment)

End of treatment

3-month follow-up

6-month follow-up

This schedule allows evaluation of both short-term outcomes and medium-term durability of rehabilitation effects.

Primary Endpoints:

The primary safety endpoint is the incidence of individual adverse events and device-related adverse events. Individual adverse events are recorded during treatment sessions, between sessions, and throughout the full follow-up period. Device-related events are recorded during sessions. The safety criterion is satisfied if both event rates remain within the acceptable thresholds defined in the device risk documentation.

The primary effectiveness endpoint is the change in cognitive and motor performance at the end of treatment. Cognitive indicators include standardized paper-and-pencil tests and additional clinical assessments; motor indicators include the Ashworth Scale and Motor Assessment Scale. The endpoint is met if improvements in the experimental group are not inferior to improvements observed in the control group.

Secondary Endpoints (Simplified):

Secondary endpoints provide additional evaluation of safety, usability, and operational feasibility of MindLenses. These include:

Technical success rate during session planning, execution, and reporting.

Procedural success rate at rehabilitation completion.

Occurrence of critical and non-critical procedural errors.

Occurrence of application errors reported by clinical staff.

Usability and logistical indicators (operator time, total therapy time, patient logistics).

Patient quality of life assessed via standardized questionnaire.

Significance:

This study provides a structured evaluation of a multimodal digital rehabilitation system integrating prism adaptation and serious games. By documenting safety, cognitive and motor outcomes, usability parameters, and clinical workflow integration, the investigation supports the validation of MindLenses as a medical device for post-stroke cognitive rehabilitation and contributes to the development of evidence-based digital neurorehabilitation strategies.