Multisensory Telerehabilitation for Visual Field Defects (MUST)

March 26, 2024 updated by: Istituto Auxologico Italiano

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, 20122
        • Istituto Auxologico Italiano IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Intervention (IM group)
HVDFs patients who start the audio-visual telerehabilitation immediately
Behavioral: Audio-visual training (AVT) telerehabilitation
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.
Experimental: WaitList Delayed Intervention (WL group)
HVDFs patients waiting 1 month before receiving the audio-visual telerehabilitation.
Behavioral: Audio-visual training (AVT) telerehabilitation
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.
No Intervention: Healthy Participants
A group of 12 healthy participants is recruited for comparisons of MRI-based connectivity metrics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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)
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
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.
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
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).
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)
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.
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)
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).
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)
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
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)
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).
At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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")
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
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
A scale assessing the presence of anxiety
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
A scale assessing the presence of depressive symptoms
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
A scale assessing the presence of anxiety in children
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
A scale assessing the presence of depressive symptoms in children
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
Automated Humphrey Visual Field Analyzer.
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
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
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
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
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
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
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
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
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
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
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
High Angular Resolution Diffusion Imaging (HARDI) index of mean diffusivity
At baseline (at the beginning of the treatment) and at the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Auxologico Italiano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCCS Fondazione Stella Maris
Azienda Ospedaliero, Universitaria Meyer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25M621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual data will be made available on zenodo.com

IPD Sharing Time Frame

Data will become available right before the first submission of the first paper.

IPD Sharing Access Criteria

Upon request to l.diana@auxologico.it

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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