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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116760
Enrollment
18
Registered
2023-11-03
Start date
2016-01-01
Completion date
2023-12-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemianopsia, Homonymous, Stroke

Keywords

Homonymous Visual Field Defects, Hemianopia, Compensatory training, Audio-visual multisensory training, tDCS

Brief summary

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.

Interventions

DEVICEAnodal or sham tDCS

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.

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

The tDCS device has a built-in function for double blind studies, i.e., the experimenters are not aware whether they are applying real or sham tDCS.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

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) *

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the functional scale assessing the impact of vision loss in everyday life activitiesAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsA 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).
Change from baseline in RTs on the Triangle TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsComputerized 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 TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsComputerized visual search task. Participants have to point to numbers (1 to 15) in ascending order. RTs: median search times (seconds).
Change from baseline in Accuracy on the EF TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsComputerized visual search task. Participants have to search for the target letter F surrounded by distractors Es. Accuracy: the proportion of correct responses (range 0-1).
Change from baseline in Response Times (RTs) on the EF TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsComputerized visual search task. Participants have to search for the target letter F surrounded by distractors Es. RTs: median search times (seconds) of correct responses.
Change from baseline in Accuracy on the Triangle TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsComputerized 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).

Secondary

MeasureTime frameDescription
Change from baseline in RTs on the Visual Detection TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsDetection 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.
Change from baseline in Accuracy on the Visual Detection TaskAt baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-upsDetection 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026