Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- sentence comprehension performance - accuracy
研究概览
简要总结
Lewy body diseases (LBDs) represents a group of neurodegenerative disorders characterized by the abnormal accumulation of aggregates of α-synuclein protein leading to the formation of Lewy bodies (LB) and Lewy neurites resulting in cell death. LBDs consists of two major clinical entities - Parkinson's disease (PD) and dementia with LB (DLB). Vast majority of patients with LBDs either already have mild cognitive impairment (MCI) at the time of the diagnosis or will develop it during the course of the disease. Language dysfunctions in LBDs patients with MCI are often unrecognized, which are difficult to treat, but even subtle changes might lead to impairment of social and occupational functioning with profound effect on their quality of lives. Current pharmacological or surgical strategies are effective for tackling the motor issues of LBDs with very limited effects on other symptoms such as language dysfunctions. Therefore, non-pharmacological approaches are gaining more attention. One of these non-pharmacological strategies is the use of noninvasive brain stimulation (NIBS) techniques that are able to modulate the brain functions with the effects on human nervous system plasticity. In this proposed project the investigators aim to first describe specific alterations in the language domain in LBDs patients with MCI as compared to healthy controls (HC) and identify the neural underpinnings of these changes using novel combination of advanced multimodal imaging techniques and various analytical methods. Secondly, the investigators aim to use NIBS as a supervised and individualized home-based therapeutical approach to tackle the language dysfunctions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •right-handedness
- •Czech as their first language
- •age (60-80 years)
- •presence of PD-MCI (Litvan et al. 2012) or MCI-LB (McKeith et al. 2020) for LBD subjects
排除标准
- •cardio pacemaker
- •any MRI-incompatible metal in the body
- •any diagnosed psychiatric disorders
- •alcohol/drug abuse
- •for HC group the presence of LBDs or other neurodegenerative disorder or MCI/dementia
研究组 & 干预措施
Differences between LBDs patients and HC in regulation of language functions
In this study, 25 LBDs patients and 25 HC will undergo neuropsychological assessment, speech and writing recording, and MRI (structural T1 sequences, sentence comprehension fMRI task, neuromelanin-sensitive MRI sequence, and resting state measurement). The HC group will be matched to the LBDs patients with MCI for gender and age.
Long-term effects of repeated sessions of home-based tDCS delivered via telepractice
The investigators will use a parallel-group, double-blinded, randomized, sham-stimulation-controlled design. Forty LBDs patients will be randomized into two parallel groups, n = 20 subjects in each arm. For the active group, the investigators will use the stimulation protocol with the anode over the left IFG (cathode over the right supraorbital area, 2mA, 20 minutes). Participants will undergo a baseline assessment (A0, as described in arm 1); 10 stimulation sessions (in a two-week period); a follow-up assessment immediately after tDCS treatment (A1), and follow-up assessments 8 weeks (A2) after the baseline assessment. Each assessment will consist of a brief neuropsychological assessment, speech and writing recording and MRI scanning.
干预措施: transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
sentence comprehension performance - accuracy
时间窗: through study completion, an average of 1 year
the investigators will study comprehension of syntactically complex sentences - accuracy in sentence comprehension task
sentence comprehension performance - reaction times
时间窗: through study completion, an average of 1 year
the investigators will study comprehension of syntactically complex sentences - reaction times in sentence comprehension task
次要结局
- The neural underpinning of sentence comprehension deficits - structural MRI data(through study completion, an average of 1 year)
- The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data(through study completion, an average of 1 year)
- the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy(On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment)
- the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - structural MRI data(On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment)
- The neural underpinning of sentence comprehension deficits - resting state data(through study completion, an average of 1 year)
- the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data(On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment)
- relation of sentence comprehension performance to cognitive performance(through study completion, an average of 1 year)
- the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - reaction times(On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment)
- the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - resting state data(On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment)