StrokeNCT07322614
Neurorehabilitation With Mindlenses in Stroke Patients
A study testing MindLenses Cognitive Training in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- MindLenses Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Clinical Trial of Neurorehabilitation With Mindlenses in Stroke Patients
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- MindLenses Cognitive Training
- Keywords
- Post-Stroke Cognitive Rehabilitation, Prism Adaptation, Serious Games, MindLenses, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindLenses Cognitive TrainingDevice
Also called Prism Adaptation + Serious Games
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after completion of treatment, 3-month follow-up, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start19 Mar 2021
- Primary completion10 Feb 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322614
- Sponsor's protocol ID
- RNT-CT#2
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stanzione A, Casula EP, Caruso G, Di Garbo A, Turriziani P, Carlesimo GA, Oliveri M. Enhancing poststroke cognitive recovery with Mindlenses, a combined prism adaptation and serious game device: a randomized controlled trial. Ann Phys Rehabil Med. 2026 Sep 18;69(8):102168. doi: 10.1016/j.rehab.2026.102168. Online ahead of print.
PubMed 42759357
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Trial of Neurorehabilitation With Mindlenses in Stroke Patients
- ClinicalTrials.gov ID
- NCT07322614
- Acronym / sponsor ID
- RNT-CT#2
- Conditions
- Stroke
- Keywords
- Post-Stroke Cognitive Rehabilitation, Prism Adaptation, Serious Games, MindLenses, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: MindLenses Cognitive Rehabilitation | Experimental | Device: MindLenses Cognitive TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindLenses Cognitive TrainingAlso: Prism Adaptation + Serious GamesCognitive 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. | Device | Experimental: MindLenses Cognitive Rehabilitation |
Primary outcome
Global Cognitive Function Change Over Time
Time frame: Baseline, immediately after completion of treatment, 3-month follow-up, and 6-month follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 42759357Stanzione A, Casula EP, Caruso G, Di Garbo A, Turriziani P, Carlesimo GA, Oliveri M. Enhancing poststroke cognitive recovery with Mindlenses, a combined prism adaptation and serious game device: a randomized controlled trial. Ann Phys Rehabil Med. 2026 Sep 18;69(8):102168. doi: 10.1016/j.rehab.2026.102168. Online ahead of print.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindLenses Cognitive Training in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Function Change Over Time (time frame: Baseline, immediately after completion of treatment, 3-month follow-up, and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07322614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.