Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events of Transcranial Alternating Current Stimulation Protocol
研究概览
简要总结
The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of transcranial alternating current stimulation (tACS) in patients with Lewy Body Dementia (DLB).
In neurodegenerative diseases, like DLB, the process of neurodegeneration is accompanied by a significant alteration in oscillatory activity.
tACS is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that uses a mild electrical current. Recent studies have demonstrated the safety and efficacy of this method in modulating the natural brain oscillation frequencies underlying multiple cognitive processes, such as verbal memory, perception, and working memory. Preliminary data show that single stimulation with occipital α-tACS results in a significant improvement in visuospatial abilities and executive functions in patients wih DLB.
The study is double blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks, from Wednesday to Tuesday (5 sessions/week, lasting approximately 60 minutes each); and group 2, participants will receive placebo tACS for 2 weeks (5 sessions/week, lasting approximately 60 minutes each).
Visits will take place at the beginning of the study (T00), after 2 weeks (T02), and 12 weeks (T12, follow-up). During each visit, participants undergo the following procedures: (i) blood sampling, (ii) clinical and neuropsychological assessment, (iii) EEG, and (iv) TMS-EEG. The occurrence of adverse events will be monitored throughout the duration of the study. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.
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, 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
- •Male or female subjects aged over 18 at the time of signing the informed consent form;
- •Presence of a clinical diagnosis of Lewy body dementia according to clinical criteria (McKeith et al., 2017)
排除标准
- •Age younger than that stated in the inclusion criteria;
- •Incapacity to understand;
- •Contraindications for tACS and TMS: patients with cardiac pacemakers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety questionnaire)
研究组 & 干预措施
Sham Comparator: Sham tACS
10 sessions of sham Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
干预措施: Sham Transcranial Alternating Current Stimulation (Device)
Experimental: Real tACS
10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
干预措施: Transcranial Alternating Current Stimulation (Device)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events of Transcranial Alternating Current Stimulation Protocol
时间窗: Through study completion, at week 12
Safety and tolerability will be assessed in terms of incidence and severity of any adverse events. Safety and tolerability will be monitored throughout the duration of the study.
Feasibility of Transcranial Alternating Current Stimulation Protocol
时间窗: Through study completion, at week 12
Feasibility will be assessed based on the drop-out rate. Feasibility will be monitored throughout the duration of the study.
Mini-Mental State Examination (MMSE)
时间窗: Change from baseline to week 12
The global cognitive functioning will be assessed by Mini-Mental State Examination (MMSE); MMSE scores range from 0 to 30, with higher scores indicating a more preserved cognition.
Neuropsychiatric Inventory (NPI)
时间窗: Change from baseline to week 2 and 12
Neuropsychiatric Inventory (NPI) is designed to be a structured clinical interview about neuropsychiatric and behavioral symptoms will be assessed by; the score ranges from 0 (no symptoms) to 144 (severe symptoms).
Qualitive Pentagon Test
时间窗: Change from baseline to week 2 and 12
Praxis-constructive abilities will be assessed by Qualitive Pentagon Test; the subject is asked to copy two intersecting pentagons. Qualitive Pentagon Test scores range from 0 to 13, with higher scores indicating a better performance.
Rey Auditory Verbal Learning Test (RAVLT)
时间窗: Change from baseline to week 2 and 12
Verbal memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), including immediate recall (sum of trials), delayed recall after 15 minutes. Scores reflect the number of correctly recalled items.
Trail Making Test (TMT - AB)
时间窗: Change from baseline to week 2 and 12
Executive function will be assessed using the Trail Making Test, including Part A (visual attention and processing speed) and Part B (task switching and cognitive flexibility). Higher completion times reflect poorer performance.
Clock Drawing Test (CDT)
时间窗: Change from baseline to week 2 and 12
Constructional praxis abilities, mental representation skills, and visuospatial planning will be evaluated by Clock Drawing Test (CDT). CDT scores range from 0 to 15, with higher scores indicating a better performance.
Rey-Osterrieth Complex Figure Test (ROCF)
时间窗: Change from baseline to week 2 and 12
Visuoconstructive abilities and visual memory will be assessed by Rey-Osterrieth Complex Figure. It requires the subject to copy a complex geometric figure and subsequently reproduce it from meory after a 10 minutes delay. Both tests score from 0 to 36, with higher score indicating a better performance.
Phonemic Fluency Test
时间窗: Change from baseline to week 2 and 12
Cognitive flexibility and verbal fluency will be evalueted by Phonemic Fluency Test. Subject is asked to generate as many words as possible from a given letter within a limited time (60 seconds); higher scores indicate better perfomance.
Semantic Fluency Test
时间窗: Change from baseline to week 2 and 12
Lexical-semantic access and executive functioning will be evalueted by Semantic Fluency Test. Subject is asked to generate as many words as possible from a given category within a limited time (60 seconds); higher scores indicate better perfomance.
Digit Span Test
时间窗: Change from baseline to week 2 and 12
Short-term memory and working memory will be assessed respectively using the Digit Span forward and Digit Span backward. Scores reflect the maximum number of digits recalled in correct order.
Visual Search Task
时间窗: Change from baseline to week 2 and 12
Attention and cognitive flexibility will be assessed using a Visual Search task. Participants will be instructed to identify and select a predefined target each time it appears on the screen. Performance will be quantified by the number of correct detections (hits), missed targets (omissions), and incorrect responses (errors).
次要结局
- Change in Biological Markers(Change from baseline to week 2 and 12)
- Change in electroencephalography (EEG)(Change from baseline to week 2 and 12)
- Change in TMS-EEG(Change from baseline to week 2 and 12)
- Basic Activities of Daily Living (BADL)(Baseline)
- Instrumental Activities of Daily Living (IADL)(Baseline)
- Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)(Baseline)
- Demographic characteristics(Baseline)
研究者
Prof. Barbara Borroni
Professor
IRCCS Centro San Giovanni di Dio Fatebenefratelli