Anodal tDCS With Compensatory Audio-visual Training for Acquired Visual Field Defects After Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline in Accuracy on the Triangle Task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Presence of chronic (>3 months) HVFD according to Neurophtalmological evaluation, due to acquired brain injury (i.e., stroke, traumatic brain injury, brain tumor)
排除标准
- •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)
研究组 & 干预措施
Anodal Occipital tDCS + audio-visual training
Anodal 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.
干预措施: Anodal or sham tDCS (Device)
Anodal Occipital tDCS + audio-visual training
Anodal 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.
干预措施: Audio-visual training (Behavioral)
Anodal Parietal tDCS + audio-visual training
Anodal 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.
干预措施: Anodal or sham tDCS (Device)
Anodal Parietal tDCS + audio-visual training
Anodal 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.
干预措施: Audio-visual training (Behavioral)
Sham tDCS + audio-visual training
Arm 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.
干预措施: Audio-visual training (Behavioral)
Sham tDCS + audio-visual training
Arm 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.
干预措施: Anodal or sham tDCS (Device)
结局指标
主要结局
Change from baseline in Accuracy on the Triangle Task
时间窗: At 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 Response Times (RTs) on the EF Task
时间窗: At 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.
Change from baseline in Accuracy on the EF Task
时间窗: At 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 Task
时间窗: At 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 activities
时间窗: At 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 Task
时间窗: At 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).
次要结局
- Change from baseline in RTs on the Visual Detection Task(At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups)
- Change from baseline in Accuracy on the Visual Detection Task(At baseline (at the beginning of the treatment), at the end of the treatment, at 1- and 4-month follow-ups)