Visual Field Defect Following Cerebrovascular AccidentMUSTNCT06341777

Multisensory Telerehabilitation for Visual Field Defects

A study testing Audio-visual training (AVT) telerehabilitation in people with Visual Field Defect Following Cerebrovascular Accident and Hemianopia, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 70 years
Conditions the study is for: Visual Field Defect Following Cerebrovascular Accident, Hemianopia, Brain Injuries
What is being tested?: Audio-visual training (AVT) telerehabilitation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteItaly
Study dates: 1 Jan 2020to 31 Dec 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 6 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Acquired homonymous visual field defect (HVFDs) due stroke, traumatic brain injury, tumor, surgery for epilepsy in a chronic stage of illness (time from the lesion >6 months)
Normal hearing
Normal or corrected-to-normal visual acuity

Who cannot join

cognitive decline (adults)
intellectual disability (children)
major neurological or psychiatric disease
being enrolled in another therapy for HVFDs
not being enrolled in another VFDs therapy.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Auxologico Italiano IRCCS
Milan, Lombardy, 20122

Other trials in Italy

About this study

Official title: Telerehabilitation for Visual Field Defects: Clinical Efficacy of a Novel Multisensory Therapy for Adults and Children With Acquired Brain Lesions

Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements.

Conditions: Visual Field Defect Following Cerebrovascular Accident, Hemianopia, Brain Injuries
Being tested: Audio-visual training (AVT) telerehabilitation
Medical subject headings: Hemianopsia, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Audio-visual training (AVT) telerehabilitationBehavioural
Participants are trained at home, with remote supervision, for 3 weeks (5 days/week, 2 hours/day) using an audio-visual device suitable for telerehabilitation (AVDESK, Linari Medical). Specifically, visual stimuli (LEDs) appear on a semicircular panel, either alone or paired with an acoustic cues, at different eccentricities. Stimuli to the blind visual field (70%) and intact visual field (30%) are presented in random sequence. Patients are trained to scan the visual field by shifting their gaze (from the central fixation point) towards the visual target (with or without sounds), without head movements, and to report its presence by pressing the response key.

Study groups in NCT06341777
Study group	Role	What they receive
Immediate Intervention (IM group)	Experimental	HVDFs patients who start the audio-visual telerehabilitation immediately Receives: Behavioral: Audio-visual training (AVT) telerehabilitation
WaitList Delayed Intervention (WL group)	Experimental	HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation. Receives: Behavioral: Audio-visual training (AVT) telerehabilitation
Healthy Participants	No intervention	A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Accuracy on the EF Task
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Change from baseline in Response Times (RTs) on the EF Task
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Change from baseline in Accuracy on the Triangle Task
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. Accuracy: the proportion of correct responses (range 0-1)
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Triangle Task
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. RTs: median search times (seconds) of correct responses.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Numbers Task
Computerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in omissions on the Bell Test (only children)
Participants have to cross out Bells (targets) among different distractors. Omissions: number of omitted targets.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Bell Test (only children)
Participants have to cross out Bells (targets) among different distractors. RTs: median search times (seconds).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in Accuracy on the Small Faces Test (only children)
Participants have to cross out targets among distractors. Accuracy: the number of correct responses
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in RTs on the Small Faces Test (only children)
Participants have to cross out targets among distractors; RTs: median search times (seconds).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups

Secondary outcomes (14)

Change from baseline in Daily Living Dependent on Vision Questionnaire (total score)
A scale assessing the impact of HVFDs on nine activities of daily living. For each item, the score ranges from 0 ("No difficulty") to 4 ("Very frequent difficulties")
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Reading test (reading time)
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Hamilton Anxiety Scale (total score; only adults)
A scale assessing the presence of anxiety
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults)
A scale assessing the presence of depressive symptoms
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children)
A scale assessing the presence of anxiety in children
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Children Depression Inventory (CDI; total score; only children)
A scale assessing the presence of depressive symptoms in children
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the visual field size (only adults)
Automated Humphrey Visual Field Analyzer.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the amplitude of Visual Evoked Potentials (VEPs)
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the latency of Visual Evoked Potentials (VEPs)
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Measured: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Superior Longitudinal Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Measured: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Measured: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Radiations
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Measured: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Tracts
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
Measured: At baseline (at the beginning of the treatment) and at the end of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202031 Dec 2023

First posted2 Apr 2024
Study start1 Jan 2020
Primary completion31 Dec 2023
Study completion31 Dec 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 Visual Field Defect Following Cerebrovascular AccidentStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06341777
Sponsor's protocol ID: 25M621
Acronym: MUST
Status last verified: Mar 2024
First submitted: 19 Mar 2024
Last updated: 2 Apr 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual data will be made available on zenodo.com

Publications

Bolognini N, Diana L, Rossetti A, Melzi L, Basso G, Manzo V, Cruz-Sanabria F, Cammarata G, Cernigliaro F, Bianchi Marzoli S, Tinelli F, Fiori S, Casati C. Telerehabilitation for visual field defects with a multisensory training: a feasibility study. J Neuroeng Rehabil. 2025 Feb 24;22(1):34. doi: 10.1186/s12984-025-01573-4.
PubMed 39994637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Recruiting
Vision Improvement Through Behavioral Rehabilitation And Neuroplasticity Training
Visual Field Defect, Stroke
Recruiting
Vision Loss Impact on Navigation in Virtual Reality
Stroke, Ischemic, Quadrantanopia
Not yet recruiting
Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
Stroke, Visual Field Defect
Recruiting
Hemianopsia Rehabilitation After Stroke or Brain Injury
Hemianopsia, Visual Field Defect, Peripheral

All Visual Field Defect Following Cerebrovascular Accident trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telerehabilitation for Visual Field Defects: Clinical Efficacy of a Novel Multisensory Therapy for Adults and Children With Acquired Brain Lesions
ClinicalTrials.gov ID: NCT06341777
Acronym / sponsor ID: MUST / 25M621
Conditions: Visual Field Defect Following Cerebrovascular Accident, Hemianopia, Brain Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Istituto Auxologico ItalianoUniversity, hospital or other
Collaborators: IRCCS Fondazione Stella Maris, Meyer Children's Hospital IRCCS
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 2 Apr 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Immediate Intervention (IM group)	Experimental	Behavioral: Audio-visual training (AVT) telerehabilitationHVDFs patients who start the audio-visual telerehabilitation immediately
WaitList Delayed Intervention (WL group)	Experimental	Behavioral: Audio-visual training (AVT) telerehabilitationHVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation.
Healthy Participants	No intervention	–A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics

Who may qualify

Ages: 6 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Acquired homonymous visual field defect (HVFDs) due stroke, traumatic brain injury, tumor, surgery for epilepsy in a chronic stage of illness (time from the lesion >6 months)
Normal hearing
Normal or corrected-to-normal visual acuity

Key exclusion criteria (5 listed)

cognitive decline (adults)
intellectual disability (children)
major neurological or psychiatric disease
being enrolled in another therapy for HVFDs
not being enrolled in another VFDs therapy.

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
Audio-visual training (AVT) telerehabilitationParticipants are trained at home, with remote supervision, for 3 weeks (5 days/week, 2 hours/day) using an audio-visual device suitable for telerehabilitation (AVDESK, Linari Medical). Specifically, visual stimuli (LEDs) appear on a semicircular panel, either alone or paired with an acoustic cues, at different eccentricities. Stimuli to the blind visual field (70%) and intact visual field (30%) are presented in random sequence. Patients are trained to scan the visual field by shifting their gaze (from the central fixation point) towards the visual target (with or without sounds), without head movements, and to report its presence by pressing the response key.	Behavioural	Immediate Intervention (IM group), WaitList Delayed Intervention (WL group)

Primary outcome

Change from baseline in Accuracy on the EF Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Change from baseline in Response Times (RTs) on the EF Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. RTs: median search times (seconds) of correct responses.
Change from baseline in Accuracy on the Triangle Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. Accuracy: the proportion of correct responses (range 0-1)
Change from baseline in RTs on the Triangle Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Computerized visual search task. Participants have to report the number of triangles (targets) surrounded by square distractors. RTs: median search times (seconds) of correct responses.
Change from baseline in RTs on the Numbers Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Computerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
Change from baseline in omissions on the Bell Test (only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Participants have to cross out Bells (targets) among different distractors. Omissions: number of omitted targets.
Change from baseline in RTs on the Bell Test (only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Participants have to cross out Bells (targets) among different distractors. RTs: median search times (seconds).
Change from baseline in Accuracy on the Small Faces Test (only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Participants have to cross out targets among distractors. Accuracy: the number of correct responses
Change from baseline in RTs on the Small Faces Test (only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Participants have to cross out targets among distractors; RTs: median search times (seconds).

14 secondary outcomes

Change from baseline in Daily Living Dependent on Vision Questionnaire (total score)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Reading test (reading time)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Hamilton Anxiety Scale (total score; only adults)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the Children Depression Inventory (CDI; total score; only children)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the visual field size (only adults)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups
Change from baseline in the amplitude of Visual Evoked Potentials (VEPs)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the latency of Visual Evoked Potentials (VEPs)
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, and at the 6-month follow-up
Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Superior Longitudinal Fasciculus
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Radiations
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment
Change from baseline in the connectivity of the Optic Tracts
Time frame: At baseline (at the beginning of the treatment) and at the end of the treatment

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 2 Apr 2024.
Derived from this study: PubMed 39994637Bolognini N, Diana L, Rossetti A, Melzi L, Basso G, Manzo V, Cruz-Sanabria F, Cammarata G, Cernigliaro F, Bianchi Marzoli S, Tinelli F, Fiori S, Casati C. Telerehabilitation for visual field defects with a multisensory training: a feasibility study. J Neuroeng Rehabil. 2025 Feb 24;22(1):34. doi: 10.1186/s12984-025-01573-4.
Individual participant dataSharing planned: Yes. Anonymized individual data will be made available on zenodo.com

Related trials for Visual Field Defect Following Cerebrovascular Accident

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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. 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?

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 3 inclusion and 5 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 2 Apr 2024. 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?

Change from baseline in Accuracy on the EF Task (time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups]). The study lists 9 primary outcomes in all. 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 NCT06341777, 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 2 Apr 2024.