Neuromodulation Through Multisensory Stimulation for Visual Field Deficits in the Subacute Stage of Disease (MULTICAMPO)

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Homonymous Hemianopsia
• Intervention / Treatment: Behavioral: Audio-visual training; Device: tDCS

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Bolognini, PhD; Phone Number: +39 02619116127; Email: n.bolognini@auxologico.it

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Recruiting
      • Istituto Auxologico Italiano IRCCS
      • Contact: Nadia Bolognini, PhD; Phone Number: +39 02619116127; Email: n.bolognini@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Presence of subacute acquired brain injury (< 3 months) with HVFD according to Neurophthalmological evaluation

Exclusion Criteria:

• Presence of hemispatial neglect (indexed by pathological asymmetries on paper-and-pencil tests)
• Disorders of conjugated eye movements
• Other neurological disorders (e.g., dementia)
• Exclusion criteria for brain stimulation (i.e., epilepsy or family history of epilepsy; implanted electrodes, stimulators, pacemakers, infusion pumps, or any implanted metal device; pregnancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal Occipital tDCS + audio-visual training; 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.	Behavioral: 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.; Device: tDCS; Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.
Sham Comparator: Sham tDCS + audio-visual training; Same montage as for Experimental group. Stimulator is turned off after 30s of the audio-visual training.	Behavioral: 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.; Device: tDCS; Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	At baseline (at the beginning of the treatment), at the end of the treatment, at 12-month follow-ups

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Blindness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemianopsia; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 25C504

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No