Cross-over Study to Evaluate the Safety, Tolerability, and Clinical Efficacy of Transcranial Alternating Current Stimulation (tACS) in Patients With Frontotemporal Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Feasibility 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 Frontotemporal Dementia (FTD).
In addition to typical symptoms, FTD also present alterations in brain oscillations. In animal models of neurodegeneration, restoration of oscillations via neuronal "entrainment" phenomena has demonstrated a significant reduction in toxic protein accumulation, resulting in improved cognitive function.
tACS is a neurophysiological noninvasive method of neuromodulation increasingly studied for its therapeutic potential. It has been shown to safely modulate the oscillatory frequencies underlying multiple cognitive functions, including verbal memory, perception, and working memory.
In light of this evidence, it is proposed to apply a single-session treatment of β-tACS stimulation in patients with FTD and to evaluate its clinical effects, oscillatory modifications by EEG, and changes in neurophysiological indices such as short intracortical inhibition (SICI) and intracortical facilitation (ICF), both compromised in the disease.
The study has a cross-over design (multicenter, randomized, placebo-controlled and double-blind), with FTD patients randomly assigned to one of the two arms: i) Group 1, who will receive a real tACS session first (1h); ii) Group 2, who will instead undergo a sham tACS session (1h). In the next phase (cross-over), one week after the first phase, the groups will reverse the treatment: Group 1 will receive tACS sham and Group 2 will receive real tACS.
The main objectives of the study are: [1] to evaluate the safety and tolerability of the single tACS treatment session; [2] to investigate the effects of the protocol on (short-term) cognitive performance in patients with FTD; [3] to verify intervention-induced changes in brain synchronization; [4] to evaluate changes in neurophysiological indices following treatment; and [5] evaluate any predictors of efficacy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 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 40 years at the time of signing the informed consent form;
- •Presence of a clinical diagnosis of Frontotemporal Dementia according to clinical criteria (Rascovsky et al., 2011; Gorno-Tempini et al., 2011).
排除标准
- •Age younger than that stated in the inclusion criterion;
- •Inability to understand;
- •Contraindications for tACS and TMS: cardiac pacemaker carriers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety Questionnaire)
结局指标
主要结局
Safety and Feasibility of Transcranial Alternating Current Stimulation Protocol
时间窗: Periprocedurally, an average 1 week
Safety will be assessed in terms of the frequency and severity of any adverse events, and feasibility will be assessed based on the study dropout rate. Safety and feasibility will be monitored throughout the study.
Phonemic Fluency Test
时间窗: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
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: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
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.
Trail Making Test (TMT - AB)
时间窗: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
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.
Digit Span Test
时间窗: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
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.
Modified Emotion Recognition Test
时间窗: Immediately after first stimulation. Immediately after second stimulation, after a week.
Emotion recognition from facial expressions will be evalueted by Modified Emotion Recognition Test. Subject is asked to choose an emotion from five options for each face showed; higher scores indicate better perfomance.
Berg's Card Sorting Task
时间窗: At the end of first stimulation. At the end of second stimulation, after a week.
Cognitive flexibility and problem solving will be assessed by Berg's Card Sorting Task. Scores reflect correct answer, errors and reaction time.
Go/No-Go Task
时间窗: At the end of first stimulation. At the end of second stimulation, after a week.
Inhibition control will be assessed by Go/No-Go Task. Scores reflect correct targets, false alarms, misses and response speed.
次要结局
- Change in electroencephalography (EEG)(Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.)
- Effectiveness in restoring neurotransmission(Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.)
- Demographic characteristics(Baseline)
研究者
Prof. Barbara Borroni
Professor
IRCCS Centro San Giovanni di Dio Fatebenefratelli