Homonymous HemianopsiaMULTICAMPONCT07358832
Neuromodulation Through Multisensory Stimulation for Visual Field Deficits in the Subacute Stage of Disease
A study testing tDCS and Audio-visual training in people with Homonymous Hemianopsia and Stroke, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homonymous Hemianopsia, Stroke
- What is being tested?
- tDCS and Audio-visual training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of subacute acquired brain injury (< 3 months) with HVFD according to Neurophthalmological evaluation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, Lombardy, 20122
Nadia Bolognini, PhD, 02619116127 ext. +39, n.bolognini@auxologico.it
About this study
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).
Read more
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
- Being tested
- tDCS, Audio-visual training
- Medical subject headings
- Hemianopsia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Anodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.
Audio-visual trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS; Behavioral: Audio-visual training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homonymous HemianopsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358832
- Sponsor's protocol ID
- 25C504
- Acronym
- MULTICAMPO
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Through Multisensory Stimulation for Visual Field Deficits in the Subacute Stage of Disease
- ClinicalTrials.gov ID
- NCT07358832
- Acronym / sponsor ID
- MULTICAMPO / 25C504
- Conditions
- Homonymous Hemianopsia, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal Occipital tDCS + audio-visual training | Experimental | Device: tDCS, Behavioral: Audio-visual trainingAnodal 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. |
| Sham tDCS + audio-visual training | Sham comparator | Device: tDCS, Behavioral: Audio-visual trainingSame montage as for Experimental group. Stimulator is turned off after 30s of the audio-visual training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of subacute acquired brain injury (< 3 months) with HVFD according to Neurophthalmological evaluation
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAnodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training. | Device | Anodal Occipital tDCS + audio-visual training, Sham tDCS + audio-visual training |
| Audio-visual training90 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. | Behavioural | Anodal Occipital tDCS + audio-visual training, Sham tDCS + audio-visual training |
Primary outcome
Change from baseline in Humphrey Visual Field perimetry
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups
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.
6 secondary outcomes
Change from baseline in Accuracy and reaction time on the EF Task
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
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
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
Time frame: At baseline (at the beginning of the treatment), at 2- and 12-month follow-ups
Change in Visual Evoked Potential amplitude
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
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Audio-visual training in people with Homonymous Hemianopsia and Stroke, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Bolognini, PhD (02619116127 ext. +39, n.bolognini@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Humphrey Visual Field perimetry (time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 2- and 12-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.