The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- functional near-infrared spectroscopy
研究概览
简要总结
This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.
详细描述
Schizophrenia is a chronic, severe mental disorder characterized by a high suicide rate and significant disability. Cognitive impairment is one of the core symptoms of schizophrenia, with approximately 98% of patients experiencing a decline in cognitive function compared to pre-illness levels. Research has found that individuals with schizophrenia show significant impairments in seven domains, including reaction time, attention, working memory, verbal learning and memory, visual learning and memory, logical reasoning, and social cognition.
Pharmacological treatment remains the primary approach for managing schizophrenia. However, cognitive impairment in individuals with schizophrenia often does not respond well to medication. Additionally, electroconvulsive therapy (ECT) may have potential cognitive side effects. Transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, has been found in several studies to improve cognition. However, its effectiveness is not yet clear.
Conventional tACS utilizes weak currents below 4mA, which can only directly stimulate certain cortical areas and indirectly stimulate deep brain structures. Moreover, the targeting of specific brain regions can be complex, and users may experience a sensation of heat on the skin where the electrodes come into contact.High-frequency transcranial alternating current stimulation (Hi-tACS) employs electrical currents greater than 10mA, typically ranging from 10-15mA. Unlike conventional tACS, Hi-tACS can apply stimulation to the entire brain, potentially enhancing its therapeutic effects. Moreover, Hi-tACS does not require precise targeting and is generally well-tolerated without any discomfort during the stimulation. It is considered a promising and potentially safe treatment modality for cognitive impairment in schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Meets the diagnostic criteria for schizophrenia according to DSM-
- •Age ≥ 18 years old.
- •Right-handed.
- •Willing to participate in this study and sign an informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, a legal guardian must act as a proxy during the informed consent process and sign the form.
- •Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.
- •Montreal Cognitive Assessment score ≥ 10 points.
排除标准
- •Psychotic disorders caused by split affective disorder, bipolar disorder, intellectual disability, anxiety spectrum disorders, drugs, alcohol, and other psychoactive substances according to DSM-V diagnostic criteria.
- •Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.
- •Those who have received MECT or TMS treatment within 1 month before enrollment.
- •Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.
- •Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).
- •Participation in any other clinical trials within 1 month prior to baseline.
- •Pregnant and lactating women.
- •The investigator believes that there are inappropriate conditions for participating in this study.
研究组 & 干预措施
treatment arm
The frequency of the stimulation was 77.5Hz and the intensity was 15mA. Each participant was treated twice a day for 40 minutes each time, with an interval of more than 3 hours between the two sessions for 30 days
干预措施: high-frequency transcranial alternating current stimulation (Device)
sham-treatment arm
The frequency of the stimulation was 77.5Hz and the intensity was 0mA. Each participant was treated twice a day for 40 minutes each time, with an interval of more than 3 hours between the two sessions for 30 days
干预措施: sham high-frequency transcranial alternating current stimulation (Device)
结局指标
主要结局
functional near-infrared spectroscopy
时间窗: 20 days of treatment
Functional near-infrared spectroscopy (fNIRS) measures the oxygen content of the cerebral cortex and provides the values of oxy-emoglobin and deoxygenatedhemoglobin in real time, indicating the level of brain activity
scores of Repeatable Battery for the Assessment of Neuropsychological Status
时间窗: 20 days of treatment
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a standardized cognitive assessment tool used in clinical and research settings. It evaluates cognitive abilities such as attention, memory, language, and visuospatial skills. The RBANS consists of 12 subtests and takes about 45-60 minutes to complete. It is efficient, providing a comprehensive assessment of cognitive functioning. The RBANS is extensively validated and normed, making it reliable for assessing cognitive performance. It provides standardized scores for comparison with peers, making it useful for detecting cognitive impairments. Overall, the RBANS is a valuable tool for evaluating cognitive functioning and tracking changes over time.
次要结局
- scores of Hamilton Depression Scale(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- scores of Pittsburgh sleep quality index(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- scores of Positive and Negative Syndrome Scale(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- scores of Auditory Hallucinations Rating Scale(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- scores of Montreal Cognitive Assessment Scale(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- Magnetic resonance imaging(1 day before the start of the treatment, 20 days of treatment)
- scores of Hamilton Anxiety Scale(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- The Clinical Assessment Interview for Negative Symptoms(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
- Brain-derived neurotrophic factor(1 day before the start of the treatment, 20 days of treatment, 30 days after treatment)
研究者
Jinsong Tang
Deputy chief physician
Sir Run Run Shaw Hospital