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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06341777
Other study ID # 25M621
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan Lombardia

Sponsors (3)

Lead Sponsor Collaborator
Istituto Auxologico Italiano Azienda Ospedaliero, Universitaria Meyer, IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]
Primary 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]
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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