The Impact of Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex at Different Intensities and Frequencies on Cognition of Schizophrenic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Spatial Working Memory behavioral performance
研究概览
简要总结
The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.
详细描述
In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Allocation Concealment is used to perform a random sequence on study participants. Also, non-transparent envelopes sealed with random sequences will be used, in a way that each random sequence is recorded on a card, and the cards are placed in the envelope in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box. At the beginning of the registration, according to the order of entry of the eligible participants, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
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
- •Diagnosis of schizophrenia based on DSM V,
- •Being 18-50 years old (male and female)
- •If female, negative urine pregnancy test
- •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
- •Required written informed consent signed by patients' guardian
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 brain stimulation 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).
结局指标
主要结局
Spatial Working Memory behavioral performance
时间窗: During procedure (4 minutes)
The test begins with a number of coloured squares (boxes) shown on the screen. The aim of this test is that by selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen.
executive function behavioral performance
时间窗: During procedure (8-10 minutes)
The participant is shown two displays containing three coloured balls. The test administrator first demonstrates to the participant how to move the balls in the lower display to copy the pattern in the upper display and completes one demonstration problem, where the solution requires one move. The participant must then complete three further problems, one each requiring two moves, three moves and four moves. Next the participant is shown further problems and must work out in their head how many moves the solutions require and then select the appropriate box at the bottom of the screen to indicate their response
Emotional recognition behavioral performance
时间窗: During procedure (60 minutes)
Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200 milliseconds and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise)
次要结局
- The Positive and Negative Affect Schedule (PANAS)(through study completion in each experimental session up to 1 hour)
研究者
Mohammad Ali Salehinejad
Principal Investigator
The National Brain Mapping Laboratory (NBML)