StrokeNCT06116760

Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury

A study testing Audio-visual training in people with Stroke and Hemianopsia, Homonymous, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stroke, Hemianopsia, Homonymous
What is being tested?: Audio-visual training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteItaly
Study dates: 1 Jan 2016to 31 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of chronic (>3 months) HVFD according to Neurophtalmological evaluation, due to acquired brain injury (i.e., stroke, traumatic brain injury, brain tumor)

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.

Italy1 site

Istituto Auxologico Italiano IRCCS
Milan, Lombardy, 20122

Other trials in Italy

About this study

Homonymous visual field defects (HVFDs) following acquired brain lesions affect independent living by hampering several activities of everyday life. Available treatments are intensive and week- or month-long. Transcranial Direct current stimulation (tDCS), a plasticity-modulating non-invasive technique, could be combined with behavioral trainings to boost their efficacy or reduce treatment duration. Some promising attempts have been made pairing occipital tDCS with visual restitution training, however less is knows about which area/network should be best stimulated in association with compensatory approaches, aimed at improving exploratory abilities, such as multisensory trainings.

In the present double-blind, sham-controlled study, we assess the efficacy of a multisensory training combined with tDCS. 3 groups of participants with chronic HVFDs underwent a 10-day (1.5 hrs/day) compensatory audio-visual training combined with either real anodal tDCS applied to the ipsilesional occipital tDCS (Group 1), or the ipsilesional posterior parietal cortex (Group 2), or a sham, placebo, tDCS (Group 3).

The training require the participants to orient their gaze training spatio-temporally congruent, cross-modal, audio-visual stimuli (starting from a central fixation) and press a button as quick as possible upon the detection of the visual stimulus. All stimuli are presented on 2mx2m panel embedded with 48 LEDs and loudspeakers (Bolognini et al., 2010, Brain Research)

All participants underwent a neuropsychological assessment of visuospatial functions prior to the beginning of the training (t0), at the end of the training (t1), and at 1-month (t2) and 4-month follow-up (t3). The assessment includes: a visual detection task, three visual search tasks (EF, Triangles, and Numbers; Bolognini et al., 2005, Brain), and a questionnaire about functional impact of the HVFDs in the activities of daily living.

Conditions: Stroke, Hemianopsia, Homonymous
Being tested: Anodal or sham tDCS, Audio-visual training
Keywords: Homonymous Visual Field Defects, Hemianopia, Compensatory training, Audio-visual multisensory training, tDCS
Medical subject headings: Stroke, Hemianopsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anodal or sham 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 groups in NCT06116760
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: Anodal or sham tDCS; Behavioral: Audio-visual training
Anodal Parietal tDCS + audio-visual training	Experimental	Anodal tDCS on ipsilesional posterior parietal cortex. Anode electrode placed on P3/P4 (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: Anodal or sham tDCS; Behavioral: Audio-visual training
Sham tDCS + audio-visual training	Sham comparator	Arm 3: sham tDCS. Half of participants with Group 1 montage, the other half with Group 2 montage. Stimulator is turned off after 30s of the audio-visual training. Receives: Device: Anodal or sham 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 Accuracy 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).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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).
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Change from baseline in the functional scale assessing the impact of vision loss in everyday life activities
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").
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups

Secondary outcomes (2)

Change from baseline in Accuracy 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.
Measured: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Change from baseline in RTs on the Visual Detection Task
Detection of visual stimuli presented on the same panel employed for the training. 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 1- and 4-month follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201631 Dec 2023

First posted3 Nov 2023
Study start1 Jan 2016
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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
Model description: Three groups of participants were allocated to three different experimental treatments: Group 1: audio-visual training + ipsilesional occipital tDCS Group 2: audio-visual training + ipsilesional posterior parietal tDCS Group 3: audio-visual training + sham, placebo tDCS
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06116760
Sponsor's protocol ID: 25C901
Status last verified: Mar 2024
First submitted: 31 Oct 2023
Last updated: 12 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual, anonymized, data will be uploaded on Zenodo.

Publications

Bolognini N, Rasi F, Coccia M, Ladavas E. Visual search improvement in hemianopic patients after audio-visual stimulation. Brain. 2005 Dec;128(Pt 12):2830-42. doi: 10.1093/brain/awh656. Epub 2005 Oct 11.
PubMed 16219672
Bolognini N, Fregni F, Casati C, Olgiati E, Vallar G. Brain polarization of parietal cortex augments training-induced improvement of visual exploratory and attentional skills. Brain Res. 2010 Aug 19;1349:76-89. doi: 10.1016/j.brainres.2010.06.053. Epub 2010 Jul 1.
PubMed 20599813
Diana L, Casati C, Melzi L, Marzoli SB, Bolognini N. Enhancing multisensory rehabilitation of visual field defects with transcranial direct current stimulation: A randomized clinical trial. Eur J Neurol. 2025 Jan;32(1):e16559. doi: 10.1111/ene.16559. Epub 2024 Nov 28.
PubMed 39607286

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
ClinicalTrials.gov ID: NCT06116760
Acronym / sponsor ID: 25C901
Conditions: Stroke, Hemianopsia, Homonymous
Keywords: Homonymous Visual Field Defects, Hemianopia, Compensatory training, Audio-visual multisensory training, tDCS
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Istituto Auxologico ItalianoUniversity, hospital or other
Study start: 1 Jan 2016 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 3 Nov 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Three groups of participants were allocated to three different experimental treatments: Group 1: audio-visual training + ipsilesional occipital tDCS Group 2: audio-visual training + ipsilesional posterior parietal tDCS Group 3: audio-visual training + sham, placebo tDCS

Arm	Type	Receives
Anodal Occipital tDCS + audio-visual training	Experimental	Device: Anodal or sham 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.
Anodal Parietal tDCS + audio-visual training	Experimental	Device: Anodal or sham tDCS, Behavioral: Audio-visual trainingAnodal tDCS on ipsilesional posterior parietal cortex. Anode electrode placed on P3/P4 (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: Anodal or sham tDCS, Behavioral: Audio-visual trainingArm 3: sham tDCS. Half of participants with Group 1 montage, the other half with Group 2 montage. Stimulator is turned off after 30s of the audio-visual training.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Presence of chronic (>3 months) HVFD according to Neurophtalmological evaluation, due to acquired brain injury (i.e., stroke, traumatic brain injury, brain tumor)

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
Anodal or sham tDCSAnodal or sham tDCS (see "Arms") is applied during the execution of an audio-visual training.	Device	Anodal Occipital tDCS + audio-visual training, Anodal Parietal 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, Anodal Parietal tDCS + audio-visual training, Sham tDCS + audio-visual training

Primary outcome

Change from baseline in Accuracy on the EF Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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).
Change from baseline in Response Times (RTs) on the EF Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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.
Change from baseline in Accuracy on the Triangle Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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).
Change from baseline in RTs on the Triangle Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
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.
Change from baseline in RTs on the Numbers Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Computerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
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 1- and 4-month follow-ups
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").

2 secondary outcomes

Change from baseline in Accuracy on the Visual Detection Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Change from baseline in RTs on the Visual Detection Task
Time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 16219672Bolognini N, Rasi F, Coccia M, Ladavas E. Visual search improvement in hemianopic patients after audio-visual stimulation. Brain. 2005 Dec;128(Pt 12):2830-42. doi: 10.1093/brain/awh656. Epub 2005 Oct 11.
Background: PubMed 20599813Bolognini N, Fregni F, Casati C, Olgiati E, Vallar G. Brain polarization of parietal cortex augments training-induced improvement of visual exploratory and attentional skills. Brain Res. 2010 Aug 19;1349:76-89. doi: 10.1016/j.brainres.2010.06.053. Epub 2010 Jul 1.
Derived from this study: PubMed 39607286Diana L, Casati C, Melzi L, Marzoli SB, Bolognini N. Enhancing multisensory rehabilitation of visual field defects with transcranial direct current stimulation: A randomized clinical trial. Eur J Neurol. 2025 Jan;32(1):e16559. doi: 10.1111/ene.16559. Epub 2024 Nov 28.
Individual participant dataSharing planned: Yes. Individual, anonymized, data will be uploaded on Zenodo.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Audio-visual training in people with Stroke and Hemianopsia, Homonymous, 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: finished, as of the sponsor's last update on 12 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Accuracy on the EF Task (time frame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116760, which also lists 3 linked publications.

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 12 Mar 2024.