Multisensory Telerehabilitation for Visual Field Defects (MUST)

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: Completed
• Conditions: Brain Injuries; Hemianopia; Visual Field Defect Following Cerebrovascular Accident
• Intervention / Treatment: Behavioral: Audio-visual training (AVT) telerehabilitation

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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.	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).	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.	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).	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	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).	At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 6-month follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	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)		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	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	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	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	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.	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)		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)		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	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	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	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	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	At baseline (at the beginning of the treatment) and at the end of the treatment

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: IRCCS Fondazione Stella Maris; Azienda Ospedaliero, Universitaria Meyer

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Sensation Disorders; Vision Disorders; Blindness; Stroke; Brain Injuries; Hemianopsia
• Other Study ID 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