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

NCT07358832 | Recruiting

• 1 other identifier: 25C504
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Homonymous Hemianopsia; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in Accuracy and reaction time on the EF Task

  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

  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

  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

  At baseline (at the beginning of the treatment), at 2- and 12-month follow-ups

• Change in Visual Evoked Potential amplitude

  At baseline (at the beginning of the treatment), at the end of the treatment and at 12-month follow-ups

Study Arms (2)

Anodal Occipital tDCS + audio-visual training

EXPERIMENTAL

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

Sham tDCS + audio-visual training

SHAM COMPARATOR

Same montage as for Experimental group. Stimulator is turned off after 30s of the audio-visual training.

Device: tDCS; Behavioral: Audio-visual training

Interventions

tDCS DEVICE

Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.

Anodal Occipital tDCS + audio-visual training; Sham tDCS + audio-visual training

Audio-visual training BEHAVIORAL

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.

Anodal Occipital tDCS + audio-visual training; Sham tDCS + audio-visual training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of hemispatial neglect (indexed by pathological asymmetries on paper-and-pencil tests)
• Disorders of conjugated eye movements
• Other neurological disorders (e.g., dementia)

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Hemianopsia; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Nadia Bolognini, PhD

CONTACT

02619116127; n.bolognini@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

IT (1)