Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients: a Multicentre Experimental Study With a Placebo-controlled and Double Blind Crossover Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Language production
研究概览
简要总结
The purpose of this study is to investigate whether transcranial direct current stimulation (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language production tasks and a nonverbal executive functions task.
详细描述
Background:
Language processing is a complex brain function supported by a large network, including domain-specific language areas as well as domain-general cognitive-control networks (Friederici & Gierhan, 2013). Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), is increasingly being used as a promising therapeutic tool for psychiatric and neurological diseases (Tortella et al., 2015; Flöel, 2014). In the language domain, several studies revealed that tDCS over languagespecific areas induces changes in cortical function that enhances the recovery of language abilities in patients with post-stroke aphasia (Torres, Drebing & Hamilton, 2013; Monti et al., 2013). Beneficial effects of tDCS have also been found for stimulation over more domain-general cognitive control regions. Although research on non-invasive brain stimulation and aphasia reveals promising results, studies investigating the modulation of cognitive control-networks on lexical access are rare. Given the importance of a successful interplay between prefrontal and domain-specific language areas, possible therapeutic effects of tDCS over the prefrontal cortex (PFC) in aphasia can be of high value for rehabilitation and basic research.
Procedure:
A planned total of 30 patients will be included. In a first visit, the severity of aphasia, the medical history as well as inclusion/exclusion criteria will be evaluated. After this visit, patients will undergo two tDCS sessions (one tDCS and one S-tDCS session) with a one week interval between the sessions. Each session consists of an online (during stimulation) and an offline assessment (within 30 minutes after stimulation). Three language tasks and a nonverbal executive function task will be conducted online as well as offline in each of the two sessions (tDCS and S-tDCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Chronic aphasia due to ischemic or haemorrhagic stroke (> 6 months post-stroke)
- •French as dominant language
- •Right-handedness
- •Left hemisphere lesion with intact bilateral PFC
排除标准
- •Diagnosed dementia or psychiatric comorbidity
- •Epileptic seizure within the last 12 months
- •Metallic head implants
- •Pacemaker
- •Inability to understand procedures or insufficient language production abilities
- •pregnancy
- •strong headache on the days of the tDCS sessions
- •consumption of alcohol and/or unprescribed drugs on the days of the tDCS sessions or on the day before
研究组 & 干预措施
Sham tDCS
S-tDCS
干预措施: Sham tDCS (Device)
transcranial direct current stimulation
tDCS
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Language production
时间窗: up to 30 min
Picture naming task, repetition task and verbal fluency task
次要结局
- Nonverbal executive functions task(up to 30 min)
研究者
Jean-Marie Annoni
Prof. Dr. med.
University of Fribourg