Clinical trial NCT06116760: Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
Official title: Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemianopsia, Homonymous
Keywords: Homonymous Visual Field Defects
Hemianopia
Compensatory training
Audio-visual multisensory training
tDCS
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)
* 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)

Primary outcomes:
measure: Change from baseline in Accuracy on the EF Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in Response Times (RTs) on the EF Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in Accuracy on the Triangle Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in RTs on the Triangle Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in RTs on the Numbers Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in the functional scale assessing the impact of vision loss in everyday life activities
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Secondary outcomes:
measure: Change from baseline in Accuracy on the Visual Detection Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
measure: Change from baseline in RTs on the Visual Detection Task
timeFrame: At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: Lombardia
Study officials:
References:
citation: 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.
citation: 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.