HemianopiaSCRiCaViPSNCT07317739
Screening and Rehabilitation of Visual Field Defects in Post-Stroke Patients
A study testing Early multisensory audio-visual stimulation training and Early visual field test in people with Hemianopia and Visual Field Defect Following Cerebrovascular Accident, run by Fondazione David Chiossone - Impresa Sociale.
Trial summary
In this study, the investigators will use a wearable device capable of performing this bedside assessment to evaluate the incidence of visual field loss in post-stroke patients. Furthermore, for those with visual field loss, the investigators will investigate whether integrating multisensory audio-visual… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemianopia, Visual Field Defect Following Cerebrovascular Accident
- What is being tested?
- Early multisensory audio-visual stimulation training and Early visual field test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 99 years with stroke (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to Neurology in IRCCS San Martino Polyclinic Hospital with the ability to understand and sign the informed consent for study participation.
- Mobility of at least one upper limb.
Who cannot join
- Presence of cognitive impairment (with an MMSE score less than 24), which limits the understanding of the informed consent or the ability to perform the test.
- Difficulty moving both upper limbs.
- Presence of ocular comorbidity that could affect visual field assessment before stroke.
- Presence of fluent aphasia, neglect, or head and gaze deviation.
- Presence of disturbances in the state of consciousness
- Presence of delirium
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SCRiCaViPS Screening and Rehabilitation of Visual Field Defects in Post-Stroke Patients
In this study, the investigators will use a wearable device capable of performing this bedside assessment to evaluate the incidence of visual field loss in post-stroke patients. Furthermore, for those with visual field loss, the investigators will investigate whether integrating multisensory audio-visual rehabilitation into the standard physical rehabilitation protocol can help improve visual field loss compared to standard rehabilitation alone.
Read the detailed description
The objectives of the research are:
- To quantify the incidence and severity of visual field defects in subjects with a recent cerebrovascular accident admitted to the hospital Neurology Unit
- To evaluate the rate of spontaneous recovery of visual field defects during observation .
- To test the effectiveness of an early and intensive visual rehabilitation intervention based on multisensory stimulation in reducing the severity of the aforementioned visual defect.
The research is planned to be conducted in Genova Italy and to include 300 patients.
In this study, the investigators will recruit acute post-stroke patients from the Neurology Unit of IRCCS Policlinico San Martino hospital. The study will use a wearable device (PalmScan VF2000) to assess the visual field defects. Those with significant visual field defects will be randomly assigned to either the visual rehabilitation group, receiving visual rehabilitation treatment integrated into their physical rehabilitation protocol, or the standard group. Inclusion criteria include: age between 18 and 90 years, post-stroke patients (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to the Neurology Unit of the IRCCS Policlinico San Martino hospital, able to understand and sign the informed consent for study participation, and having mobility in at least one upper limb. Exclusion criteria include: cognitive impairment that limits understanding of the informed consent or testing, difficulty with both upper limb movements, presence of ocular comorbidity that could affect pre-ictal visual field assessment, presence of fluid aphasia, neglect or deviation of the head and gaze, impaired consciousness or delirium. Baseline assessments will be conducted at the Neurology Unit of the IRCCS Policlinico San Martino hospital.
After the baseline assessment, all participants diagnosed with visual field impairment will be assigned to the David Chiossone Foundation, with the option of being referred to a post-acute residential facility or undergoing outpatient treatment. Otherwise, patients requiring intensive care will be referred to another competent local center.
Participants will be randomly divided into two groups:
- one will receive an early visual rehabilitation protocol (experimental group), possibly supplemented with neuromotor rehabilitation, immediately after discharge from the Neurology Unit of the IRCCS Policlinico San Martino hospital, with a four-week intensive stimulation protocol. Visual rehabilitation will be administered with multisensory audiovisual stimulation (AvDesk) five days a week.
- another group will continue according to current clinical practice (control group), potentially receiving neuromotor rehabilitation until full recovery, and will have access to visual rehabilitation thereafter through the access procedures agreed with the Italian National Health Service.
After 8 weeks since they are dismissed by the hospital Neurology Unit, all patients (even those not receiving vision rehabilitation) will receive a follow-up visual field assessment using the wearable device at the David Chiossone Foundation - for the rehabilitation of blind, visually impaired, and frail people - Social Enterprise.
- Being tested
- Early multisensory audio-visual stimulation training, Early visual field test
- Keywords
- Post stroke visual defects, Screening, Visual field, Rehabilitation, Neurorehabilitation, visual-auditory stimulation
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early multisensory audio-visual stimulation trainingOther
Also called audio-visual stimulation
Multisensory audio-visual stimulation training (using the device AV DESK Linari Medical) will last four weeks. Through audiovisual stimuli produced by the Av-Desk Flexi device, patients undergo a brain cell training program that compensates for blind spots in their visual field. The recipes regulating the combinations of stimuli are provided daily, under the supervision of a physician, where the data processing unit manages the data from the stimuli provided to the patient, their response to said stimuli, and monitors their position.
The follow up visual field test will detect whether early intervention with multisensory audio-visual stimuli can improve visual field loss
Early visual field testDiagnostic test
Visual field assessment with wearable devices (PalmScan VF2000) performed at the bedside in post-stroke patients who met the inclusion criteria during their stay in the neurology hospital unit, as soon as they were stabilized.
Standard 120-point visual field tests will be performed on the left and right eyes separately, with the following quantification parameters: test duration, fixation losses, false positives, false negatives, points seen, points not seen, relative defects.
Patients with a monocular residual perimetric defect of less than 106 points seen out of 124 (equal to 85% of the stimuli presented) and in any case with a defect greater than 12 points if presented in a single quadrant, will be selected for the clinical trial and invited to repeat the same visual field evaluation, using the same wearable devices in the 2-months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Standard intervention | Other | This group of patients will continue according to current clinical practice (control group), directed towards possible neuro-motor rehabilitation until full recovery, and will have access to visual rehabilitation following full recovery of physical condition.
The follow up visual field test will detect the percentage of spontaneous recovery of the visual field defect during the observation period Receives: Diagnostic Test: Early visual field test |
| Early intervention rehabilitation | Experimental | The experimental group will be enrolled for a early rehabilitation intervention through multisensory stimulations, a rehabilitation specifically aimed at improving the visual field deficit, possibly combined with standard physical rehabilitation in temporary hospitalization facilities or protected hospital discharge. Receives: Other: Early multisensory audio-visual stimulation training; Diagnostic Test: Early visual field test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate in patients who receive training with multisensory audio-visual stimuli
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
Measured: 2 months
Spontaneous recovery rate of visual field defects after stroke
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
Measured: 2 months
Secondary outcomes (1)
Incidence of visual field defects in post-stroke patients
Number of patients with visual field defects, will be compared with literature and retrospective study on clinical records of the hospital neurology clinic.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study type: interventional. Allocation: randomized Intervention model: parallel assignment (1:1) This study involves two treatment groups of post-stroke patients with visual field defects identified during the screening activity.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione David Chiossone - Impresa Sociale
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS AOU San Martino, Genova, Italy
- Responsible party
- Sponsor
- Investigators
- Angelo Schenone, Prof., Principal investigator, University of Genova DINOGMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317739
- Sponsor's protocol ID
- SCRiCaViPS
- Acronym
- SCRiCaViPS
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCRiCaViPS Screening and Rehabilitation of Visual Field Defects in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07317739
- Acronym / sponsor ID
- SCRiCaViPS / SCRiCaViPS
- Keywords
- Post stroke visual defects, Screening, Visual field, Rehabilitation, Neurorehabilitation, visual-auditory stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione David Chiossone - Impresa SocialeUniversity, hospital or other
- Collaborators
- IRCCS AOU San Martino, Genova, Italy
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 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.
In this study, the investigators will use a wearable device capable of performing this bedside assessment to evaluate the incidence of visual field loss in post-stroke patients. Furthermore, for those with visual field loss, the investigators will investigate whether integrating multisensory audio-visual rehabilitation into the standard physical rehabilitation protocol can help improve visual field loss compared to standard rehabilitation alone.
Detailed description
The objectives of the research are:
- To quantify the incidence and severity of visual field defects in subjects with a recent cerebrovascular accident admitted to the hospital Neurology Unit
- To evaluate the rate of spontaneous recovery of visual field defects during observation .
- To test the effectiveness of an early and intensive visual rehabilitation intervention based on multisensory stimulation in reducing the severity of the aforementioned visual defect.
The research is planned to be conducted in Genova Italy and to include 300 patients.
In this study, the investigators will recruit acute post-stroke patients from the Neurology Unit of IRCCS Policlinico San Martino hospital. The study will use a wearable device (PalmScan VF2000) to assess the visual field defects. Those with significant visual field defects will be randomly assigned to either the visual rehabilitation group, receiving visual rehabilitation treatment integrated into their physical rehabilitation protocol, or the standard group. Inclusion criteria include: age between 18 and 90 years, post-stroke patients (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to the Neurology Unit of the IRCCS Policlinico San Martino hospital, able to understand and sign the informed consent for study participation, and having mobility in at least one upper limb. Exclusion criteria include: cognitive impairment that limits understanding of the informed consent or testing, difficulty with both upper limb movements, presence of ocular comorbidity that could affect pre-ictal visual field assessment, presence of fluid aphasia, neglect or deviation of the head and gaze, impaired consciousness or delirium. Baseline assessments will be conducted at the Neurology Unit of the IRCCS Policlinico San Martino hospital.
After the baseline assessment, all participants diagnosed with visual field impairment will be assigned to the David Chiossone Foundation, with the option of being referred to a post-acute residential facility or undergoing outpatient treatment. Otherwise, patients requiring intensive care will be referred to another competent local center.
Participants will be randomly divided into two groups:
- one will receive an early visual rehabilitation protocol (experimental group), possibly supplemented with neuromotor rehabilitation, immediately after discharge from the Neurology Unit of the IRCCS Policlinico San Martino hospital, with a four-week intensive stimulation protocol. Visual rehabilitation will be administered with multisensory audiovisual stimulation (AvDesk) five days a week.
- another group will continue according to current clinical practice (control group), potentially receiving neuromotor rehabilitation until full recovery, and will have access to visual rehabilitation thereafter through the access procedures agreed with the Italian National Health Service.
After 8 weeks since they are dismissed by the hospital Neurology Unit, all patients (even those not receiving vision rehabilitation) will receive a follow-up visual field assessment using the wearable device at the David Chiossone Foundation - for the rehabilitation of blind, visually impaired, and frail people - Social Enterprise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study type: interventional. Allocation: randomized Intervention model: parallel assignment (1:1) This study involves two treatment groups of post-stroke patients with visual field defects identified during the screening activity.
| Arm | Type | Receives |
|---|---|---|
| Standard intervention | Other | Diagnostic Test: Early visual field testThis group of patients will continue according to current clinical practice (control group), directed towards possible neuro-motor rehabilitation until full recovery, and will have access to visual rehabilitation following full recovery of physical condition. The follow up visual field test will detect the percentage of spontaneous recovery of the visual field defect during the observation period |
| Early intervention rehabilitation | Experimental | Other: Early multisensory audio-visual stimulation training, Diagnostic Test: Early visual field testThe experimental group will be enrolled for a early rehabilitation intervention through multisensory stimulations, a rehabilitation specifically aimed at improving the visual field deficit, possibly combined with standard physical rehabilitation in temporary hospitalization facilities or protected hospital discharge. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 99 years with stroke (excluding isolated cerebellar, brainstem, or spinal cord strokes), admitted to Neurology in IRCCS San Martino Polyclinic Hospital with the ability to understand and sign the informed consent for study participation.
- Mobility of at least one upper limb.
Key exclusion criteria (6 listed)
- Presence of cognitive impairment (with an MMSE score less than 24), which limits the understanding of the informed consent or the ability to perform the test.
- Difficulty moving both upper limbs.
- Presence of ocular comorbidity that could affect visual field assessment before stroke.
- Presence of fluent aphasia, neglect, or head and gaze deviation.
- Presence of disturbances in the state of consciousness
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 |
|---|---|---|
| Early multisensory audio-visual stimulation trainingAlso: audio-visual stimulationMultisensory audio-visual stimulation training (using the device AV DESK Linari Medical) will last four weeks. Through audiovisual stimuli produced by the Av-Desk Flexi device, patients undergo a brain cell training program that compensates for blind spots in their visual field. The recipes regulating the combinations of stimuli are provided daily, under the supervision of a physician, where the data processing unit manages the data from the stimuli provided to the patient, their response to said stimuli, and monitors their position. The follow up visual field test will detect whether early intervention with multisensory audio-visual stimuli can improve visual field loss | Other | Early intervention rehabilitation |
| Early visual field testVisual field assessment with wearable devices (PalmScan VF2000) performed at the bedside in post-stroke patients who met the inclusion criteria during their stay in the neurology hospital unit, as soon as they were stabilized. Standard 120-point visual field tests will be performed on the left and right eyes separately, with the following quantification parameters: test duration, fixation losses, false positives, false negatives, points seen, points not seen, relative defects. Patients with a monocular residual perimetric defect of less than 106 points seen out of 124 (equal to 85% of the stimuli presented) and in any case with a defect greater than 12 points if presented in a single quadrant, will be selected for the clinical trial and invited to repeat the same visual field evaluation, using the same wearable devices in the 2-months follow-up. | Diagnostic test | Early intervention rehabilitation, Standard intervention |
Primary outcome
Recovery rate in patients who receive training with multisensory audio-visual stimuli
Time frame: 2 months
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
Spontaneous recovery rate of visual field defects after stroke
Time frame: 2 months
Visual field test (120pt neuro programme) per each eye at follow up compared with the screening test. The functional rate will be in percentage (on 124 stimuli) adding 1 integer for seen points, 0.5 for relative points
1 secondary outcome
Incidence of visual field defects in post-stroke patients
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Hemianopia
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Statistical Learning as a Novel Intervention for Cortical Blindness
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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.
Angelo Schenone, Prof. principal investigator
University of Genova DINOGMI
Questions about this trial
What is this clinical trial studying?
A study testing Early multisensory audio-visual stimulation training and Early visual field test in people with Hemianopia and Visual Field Defect Following Cerebrovascular Accident, run by Fondazione David Chiossone - Impresa Sociale.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Cianciosi, Dr (0039 1083421, cianciosi@chiossone.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate in patients who receive training with multisensory audio-visual stimuli (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.