Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 7:31 PM
Study NCT ID:
NCT06116760
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
Sponsor:
Istituto Auxologico Italiano
Organization:
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 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.
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:
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?: