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Abstract：
Complex visual hallucinations are common in Lewy body dementia (LBD) and can cause significant patient and caregiver distress. Current treatments are primarily pharmacological in nature and have limited efficacy and associated side effects. The objective of this study was to assess the effects of consecutive sessions of transcranial direct current stimulation (tDCS) on visual hallucination frequency and severity in LBD, at short-term and long-term follow-up stages.
The study was a randomised, double-blind, placebo-controlled trial involving 40 participants with LBD (Mage = 75.52 years, SDage = 8.69 years) which was conducted at a single site between November 2013 and December 2017. Participants received two consecutive 20-min sessions of active (0.048 mA/cm2) or placebo tDCS, separated by a 30-min break, over 5 consecutive days. The anodal electrode was applied to the right parietal cortex (P4) and the cathodal electrode was applied to the occipital cortex (Oz). The primary outcome measure was the Neuropsychiatric Inventory (NPI) hallucinations subscale, as completed by a caregiver/informant at baseline and day 5 (short-term) follow-up, and month 1 and month 3 (long-term) follow-up. Secondary outcome measures included visual cortical excitability, as measured using transcranial magnetic stimulation, computerised attentional and visuoperceptual tasks, and measures of global cognition and cognitive fluctuations.
Complete study data were obtained from 36 participants. There was an overall improvement in visual hallucinations (NPI) for both groups at day 5 relative to baseline, with a medium-to-large effect size; however, compared to placebo, active tDCS did not result in any improvements in visual hallucinations (NPI) at day 5 relative to baseline, or at month 1 or month 3 follow-up time points. Additionally, comparisons of secondary outcome measures showed that active tDCS did not result in any improvements on any measure (visual cortical excitability, attentional and visuoperceptual tasks or cognitive measures) at any time point.
Repeated consecutive sessions of parietal anodal tDCS, and occipital cathodal tDCS, do not improve visual hallucinations or visuoperceptual function, or alter visual cortical excitability in LBD.
ISRCTN, ISRCTN40214749 . Registered on 25 October 2013.
The study was a randomised, double-blind, placebo-controlled trial involving 40 participants with LBD (Mage = 75.52 years, SDage = 8.69 years) which was conducted at a single site between November 2013 and December 2017. Participants received two consecutive 20-min sessions of active (0.048 mA/cm2) or placebo tDCS, separated by a 30-min break, over 5 consecutive days. The anodal electrode was applied to the right parietal cortex (P4) and the cathodal electrode was applied to the occipital cortex (Oz). The primary outcome measure was the Neuropsychiatric Inventory (NPI) hallucinations subscale, as completed by a caregiver/informant at baseline and day 5 (short-term) follow-up, and month 1 and month 3 (long-term) follow-up. Secondary outcome measures included visual cortical excitability, as measured using transcranial magnetic stimulation, computerised attentional and visuoperceptual tasks, and measures of global cognition and cognitive fluctuations.
Complete study data were obtained from 36 participants. There was an overall improvement in visual hallucinations (NPI) for both groups at day 5 relative to baseline, with a medium-to-large effect size; however, compared to placebo, active tDCS did not result in any improvements in visual hallucinations (NPI) at day 5 relative to baseline, or at month 1 or month 3 follow-up time points. Additionally, comparisons of secondary outcome measures showed that active tDCS did not result in any improvements on any measure (visual cortical excitability, attentional and visuoperceptual tasks or cognitive measures) at any time point.
Repeated consecutive sessions of parietal anodal tDCS, and occipital cathodal tDCS, do not improve visual hallucinations or visuoperceptual function, or alter visual cortical excitability in LBD.
ISRCTN, ISRCTN40214749 . Registered on 25 October 2013.
摘要：
复杂的视觉幻觉在路易体痴呆（LBD）中很常见，并可能导致严重的患者和护理人员困扰。目前的治疗本质上主要是药理学的,并且具有有限的功效和相关的副作用。这项研究的目的是评估连续的经颅直流电刺激（tDCS）对LBD视觉幻觉频率和严重程度的影响，在短期和长期跟踪阶段。
这项研究是随机的，双盲,安慰剂对照试验，涉及40名LBD参与者(Mage=75.52岁，SDage=8.69岁），于2013年11月至2017年12月在单个地点进行。参与者接受了两个连续20分钟的活动（0.048mA/cm2）或安慰剂tDCS，间隔30分钟，连续5天以上。将阳极电极施加到右顶叶皮层（P4），并将阴极电极施加到枕骨皮层（Oz）。主要结局指标是神经精神量表（NPI）幻觉量表，在基线和第5天（短期）随访时由护理人员/线人完成，第1个月和第3个月（长期）随访。次要结果指标包括视觉皮层兴奋性，经颅磁刺激测量，计算机化的注意力和视觉感知任务，以及全球认知和认知波动的度量。
完整的研究数据来自36名参与者。在第5天，两组的视觉幻觉（NPI）相对于基线有总体改善，具有中等到较大的效果大小；然而，与安慰剂相比，活动性tDCS在第5天相对于基线没有导致视觉幻觉（NPI）的任何改善，或在第1个月或第3个月的随访时间点。此外,次要结局指标的比较表明，活动性tDCS在任何指标上都没有任何改善(视觉皮层兴奋性，注意力和视觉感知任务或认知措施)在任何时间点。
顶叶阳极tDCS的重复连续会话，和枕骨导管tDCS，不改善视觉幻觉或视觉感知功能，或改变LBD的视觉皮层兴奋性。
ISRCTN,ISRCTN40214749。2013年10月25日注册。
这项研究是随机的，双盲,安慰剂对照试验，涉及40名LBD参与者(Mage=75.52岁，SDage=8.69岁），于2013年11月至2017年12月在单个地点进行。参与者接受了两个连续20分钟的活动（0.048mA/cm2）或安慰剂tDCS，间隔30分钟，连续5天以上。将阳极电极施加到右顶叶皮层（P4），并将阴极电极施加到枕骨皮层（Oz）。主要结局指标是神经精神量表（NPI）幻觉量表，在基线和第5天（短期）随访时由护理人员/线人完成，第1个月和第3个月（长期）随访。次要结果指标包括视觉皮层兴奋性，经颅磁刺激测量，计算机化的注意力和视觉感知任务，以及全球认知和认知波动的度量。
完整的研究数据来自36名参与者。在第5天，两组的视觉幻觉（NPI）相对于基线有总体改善，具有中等到较大的效果大小；然而，与安慰剂相比，活动性tDCS在第5天相对于基线没有导致视觉幻觉（NPI）的任何改善，或在第1个月或第3个月的随访时间点。此外,次要结局指标的比较表明，活动性tDCS在任何指标上都没有任何改善(视觉皮层兴奋性，注意力和视觉感知任务或认知措施)在任何时间点。
顶叶阳极tDCS的重复连续会话，和枕骨导管tDCS，不改善视觉幻觉或视觉感知功能，或改变LBD的视觉皮层兴奋性。
ISRCTN,ISRCTN40214749。2013年10月25日注册。
