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Completed

NCT Number: NCT06341777

Multisensory Telerehabilitation for Visual Field Defects

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.

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Key information

Conditions

Visual Field Defect Following Cerebrovascular Accident Blindness Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Eye Diseases Hemianopia Hemianopsia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Trauma, Nervous System Vision Disorders Wounds and Injuries

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Audio-visual training (AVT) telerehabilitation

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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

  9. 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).

Secondary outcomes

  1. 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")

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • IRCCS Fondazione Stella Maris
  • Meyer Children's Hospital IRCCS

Registry information

Official study title

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

Acronym: MUST

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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