An interventional study of tDCS and Audio-visual training in Homonymous Hemianopsia and Stroke, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment
Homonymous visual field defects (HVFDs) after acquired brain injuries affect daily life by impairing reading, navigation, and social activities, often impacting anxiety and depression. Spontaneous recovery is rare. Rehabilitation approaches include restorative treatments, which aim to expand the visual field through the stimulation of the so-called transition zone, and compensatory strategies, such as audio-visual training (AVT), which combines eye movement exercises with synchronized visual and auditory cues to train oculomotor scanning and overcome the visual field loss. Combining AVT with non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), may enhance recovery by promoting brain plasticity. Early evidence suggests that tDCS applied to the lesioned visual cortex during AVT can speed and stabilize improvements, potentially also restoring parts of the visual field. However, most studies on AVT have focused on chronic patients, whereas several clinical trials and international guidelines indicate that early treatment of HVFDs in the subacute phase can optimally exploit the window of maximal neural plasticity and prevent secondary degenerative processes, thereby maximizing visual recovery.
In the present randomized clinical trial, we assess the efficacy of a multisensory audio-visual training (AVT) combined with tDCS in patients with subacute HVFDs after stroke (\<3 months post-lesion). Participants are randomly assigned to two groups: AVT combined with real anodal tDCS applied to the lesioned occipital cortex (Group 1), or AVT combined with sham tDCS (Group 2).
The AVT requires participants to orient their gaze toward spatio-temporally congruent, cross-modal audio-visual stimuli (starting from a central fixation) and press a button as quickly as possible upon detecting the visual target. All stimuli are presented on 2mx2m panel embedded with 40 LEDs and loudspeakers (Diana, Casati, Melzi, Marzoli, et al., 2024). The training will be administered for 90 minutes daily over 10 consecutive days.
All participants underwent a neuro-ophthalmological evaluation and neuropsychological assessment of visuospatial functions before the beginning of the training (t0), at the end of the training (t1), at 2 months (t2) and after 1 year (t3).
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's planned enrollment of 48 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.
Browse Hemianopsia studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
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- Presence of subacute acquired brain injury (\< 3 months) with HVFD according to Neurophthalmological evaluation
Exclusion Criteria:
Anodal tDCS on ipsilesional occipital cortex. Anode electrode placed on O1/O2 (10-20 EEG system) and reference electrode placed on the contralateral forehead. Stimulation delivered at 2mA during the first 30 minutes of the audio-visual training.
Device: tDCS · Behavioral: Audio-visual training
Same montage as for Experimental group. Stimulator is turned off after 30s of the audio-visual training.
Device: tDCS · Behavioral: Audio-visual training
Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.
90 min/day x 10 days. Participants are seated in front of a 2 m × 2 m training board, at a distance of 1.2 m, in a dimly lit room. The board features 48 red light-emitting diodes (LED, diameter 1 cm, luminance 90 cd m2), distributed in six horizontal rows (eight lights per row). Forty-eight piezoelectric loudspeakers (0.4 W, 8Ω) are located above each light, producing a white-noise (80 dB, duration 100 ms). Spatio-temporally congruent, cross-modal, audio-visual stimuli are presented at one out of 48 possible positions on the board. Participants are instructed to look at the fixation point - at the center of the apparatus - and to move their eyes to detect the presence of the visual stimulus (duration=100 ms) by pressing right button of a wireless mouse.
Change from baseline in Humphrey Visual Field perimetry
Mean Deviation (MD) values of both eyes will be averaged and used for the analyses. Negative values will reflect a deviation from the expected performance in the participant's age group, hence a visual field defect.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups
Change from baseline in Accuracy and reaction time on the EF Task
Computerized visual search task. Participants have to search for the target letter "F" surrounded by distractors "E"s. Accuracy: the proportion of correct responses (range 0-1). RTs: median search times (seconds) of correct responses.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups
Change from baseline in Accuracy and Reaction times 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). RTs: median search times (seconds) of correct responses.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups
Change from baseline in Accuracy and RTs on the Visual Detection Task
Detection of visual stimuli presented on the same panel employed for the training. Accuracy (the proportion of detected stimuli; range 0-1) is calculated for both the sighted and the blind hemifields. RTs: median search times of the detected stimuli are calculated for both the sighted and the blind hemifields.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups
Change in retinal layers thickness assessed with Spectral Domain Optical Coherence Tomography
Non-invasive medical imaging technique that uses light waves to create high-resolution, cross-sectional pictures (tomograms) of retinal layers. We will assess the peripapillary retinal nerve fiber and the macular ganglion cell complex layers
Time frame: At baseline (at the beginning of the treatment), at 2- and 12-month follow-ups
Change in Visual Evoked Potential amplitude
We will record with electroencephalography pattern reversal VEPs from monocular stimulation of each visual hemifield. We will analyzed the amplitude of P100 component.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment and at 12-month follow-ups
Change from baseline in the functional scale assessing the impact of vision loss in everyday life activities
We will use the 25-item National Eye Institute Visual Function Questionnaire. The total score ranges from 0 to 100.
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 12-month follow-ups
Start is estimated for Feb 2026; primary completion for Feb 2028, 24 months later.
Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's planned 24 months is below that.
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