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

Not Applicable
Completed
Conditions
Hemianopsia, Homonymous
Stroke
Interventions
Device: Anodal or sham tDCS
Behavioral: Audio-visual training
Registration Number
NCT06116760
Lead Sponsor
Istituto Auxologico Italiano
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anodal Parietal tDCS + audio-visual trainingAnodal or sham tDCSAnodal 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 trainingAudio-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.
Anodal Occipital tDCS + audio-visual trainingAudio-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 trainingAnodal or sham tDCSArm 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.
Anodal Occipital tDCS + audio-visual trainingAnodal or sham tDCSAnodal 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 trainingAudio-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.
Primary Outcome Measures
NameTimeMethod
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-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 Accuracy on the EF TaskAt 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 RTs on the Triangle TaskAt 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 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-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").

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-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 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-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.

Secondary Outcome Measures
NameTimeMethod
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-ups

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.

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-ups

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.

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS

🇮🇹

Milan, Lombardia, Italy

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