Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06116760
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-10-31
Brief Title:
Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 areanetwork 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 15 hrsday 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
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 15 hrsday 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None