Brain Injuries, Hemianopia, Visual Field Defect Following Cerebrovascular Accident
Conditions
Brief 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.
Interventions
BEHAVIORALAudio-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.
Sponsors
IRCCS Fondazione Stella Maris
Meyer Children's Hospital IRCCS
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Accuracy on the EF Task | 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 Es. RTs: median search times (seconds) of correct responses. |
| Change from baseline in Response Times (RTs) on the EF Task | 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 Es. RTs: median search times (seconds) of correct responses. |
| Change from baseline in Accuracy on the Triangle Task | 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 | 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 | 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) | 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) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Daily Living Dependent on Vision Questionnaire (total score) | 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) |
| 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) | 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 |
| Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults) | 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 |
| Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children) | 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 |
| Change from baseline in the Children Depression Inventory (CDI; total score; only children) | 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 |
| Change from baseline in the visual field size (only adults) | 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. |
| 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 | 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 |
| Change from baseline in the connectivity of the Superior Longitudinal Fasciculus | 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 |
| Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus | 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 |
| Change from baseline in the connectivity of the Optic Radiations | 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 |
| Change from baseline in the connectivity of the Optic Tracts | 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 |
Countries
Italy
Outcome results
None listed