Investigating the Mechanism of Action of Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Working memory behavioral performance
研究概览
简要总结
The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.
详细描述
Thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. A single session of concurrent prefrontal tDCS/fMRI will be conducted. Participants will undergo baseline task performance before the intervention. One week later, they will undergo the tDCS intervention (active or sham) next to the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 24 h later again. They will be then transferred to MRI scanner right after stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
- •If female, negative urine pregnancy test
- •significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
- •feasibility for tDCS interventions according to safety guidelines
- •stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
- •fluency in the native language
- •right-handed
- •ability to provide informed consent.
排除标准
- •pregnancy
- •alcohol or substance dependence
- •history of seizure
- •history of neurological disorder
- •history of head injury
- •Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.
结局指标
主要结局
Working memory behavioral performance
时间窗: up to 24 hours after the intervention
A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment
Modifications to blood-oxygen-level-dependent (BOLD) signal
时间窗: up to 1 hour
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.
次要结局
未报告次要终点
研究者
Mohammad Ali Salehinejad
Principal Investigator
Ruhr University of Bochum