Interventional Cross-over Study to Evaluate the Efficacy of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Dementia With Lewy Bodies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Changes in Visual Search Task Test scores
研究概览
简要总结
Brain oscillations are ubiquitous in the human brain and have been implicated in cognitive and behavioral states defined in precisely tuned neural networks. In neurodegenerative disorders, neurodegeneration is accompanied by changes in oscillatory activity leading to the emerging concept of neurological and psychiatric disorders as "oscillopathies".
Dementia with Lewy bodies (DLB), which is the second most frequent cause of neurodegenerative dementia, is characterized by an important alteration of brain oscillations. The restoration of oscillations by neuronal entrainment in animal models of neurodegenerative disease has shown a significant reduction in the neuropathological load of toxic proteins, with a consequent significant increase in cognitive performance.
Transcranial alternating current brain stimulation (tACS), is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that is having an increasingly numerous spectrum of potential therapeutic applications. Recent studies have demonstrated the effectiveness of this method in modulating the natural frequencies of cerebral oscillation, underlying multiple cognitive processes such as verbal memory, perception and working memory.
On the basis of these premises, the treatment with alpha tACS is proposed in patients with DLB.
In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether a single stimulation with alpha tACS on the occipital lobes can improve symptoms in patients with DLB.
详细描述
Brain oscillations are ubiquitous in the human brain and have been implicated in cognitive and behavioral states defined in precisely tuned neural networks. In neurodegenerative disorders, neurodegeneration is accompanied by changes in oscillatory activity leading to the emerging concept of neurological and psychiatric disorders as "oscillopathies".
Dementia with Lewy bodies (DLB), which is the second most frequent cause of neurodegenerative dementia, is characterized by an important alteration of brain oscillations. The restoration of oscillations by neuronal entrainment in animal models of neurodegenerative disease has shown a significant reduction in the neuropathological load of toxic proteins, with a consequent significant increase in cognitive performance.
Transcranial alternating current brain stimulation (tACS), is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that is having an increasingly numerous spectrum of potential therapeutic applications. Recent studies have demonstrated the effectiveness of this method in modulating the natural frequencies of cerebral oscillation, underlying multiple cognitive processes such as verbal memory, perception and working memory.
On the basis of these premises, the treatment with alpha tACS is proposed in patients with DLB.
In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether a single stimulation with alpha tACS on the occipital lobes can improve symptoms in patients with DLB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia with Lewy bodies (criteria according to McKeith, Neurology 2017).
排除标准
- •Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass documented by MRI.
- •History of traumatic brain injury or other neurological diseases.
- •Serious medical illness other than DLB
- •History of seizures
- •Pregnancy
- •Metal implants in the head (except dental fillings)
- •Electronic implants (i.e. pace-maker, implanted medical pump)
- •Age <18 years
研究组 & 干预措施
real tACS
Single session of alpha tACS (12 Hz) at 3 mA over the occipital cortex.
干预措施: Alpha tACS (12 Hz) over the occipital cortex (Device)
sham tACS
Single session of sham tACS over the occipital cortex.
干预措施: Alpha tACS (12 Hz) over the occipital cortex (Device)
结局指标
主要结局
Changes in Visual Search Task Test scores
时间窗: 40 minutes after the start of the intervention
The visual search task requires participants to determine whether a target (such as a particular letter, shape, or image) is present in an array of other stimuli. The task consists of two parts, each with 64 stimuli, for a total of 128 stimuli. Participants are asked to look at the screen and press a button if the target stimulus is present or another button if the target stimulus is absent. After pressing the chosen button, a feedback will appear on the screen that will tell the subject if his answer is correct or incorrect. Subjects must respond as quickly as possible, otherwise the answer will be considered missed and they will proceed to the next screen. The score ranges from 0 (worse performance) to 128 (best performance).
次要结局
- Change in ICF measurements(Baseline (immediately before the intervention) - Immediately after the intervention)
- Changes in Trail Making Test Part A(Baseline (immediately before the intervention) - Immediately after the intervention)
- Changes in Rey Auditory Verbal Learning Test scores(Baseline (immediately before the intervention) - Immediately after the intervention)
- Changes in relative alpha power in occipital EEG leads(Baseline (immediately before the intervention) - Immediately after the intervention)
- Change in SICI measurements(Baseline (immediately before the intervention) - Immediately after the intervention)
- Changes in Trail Making Test Part B(Baseline (immediately before the intervention) - Immediately after the intervention)
- Change in SAI measurements(Baseline (immediately before the intervention) - Immediately after the intervention)
研究者
Barbara Borroni
Clinical Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia