Multisensory Telerehabilitation for Visual Field Defects

Brain Injuries Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06341777
• Other study ID #: 25M621
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Hemianopia
• Hemianopsia
• Stroke

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