Efficacy of High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) in Treating Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in negative symptoms of schizophrenia
研究概览
简要总结
The goal of this clinical trial is to investigate whether Hi-tACS is effective and safe in treating negative symptoms of schizophrenia.
Schizophrenic patients will receive treatment (Hi-tACS or shame stimulation) for 2 weeks.
Negative symptoms, cognitive functioning, social functioning, and quality of life of intervention group and control group were assessed and compared between the two groups at baseline, 2 weeks, and 3 months post-intervention.
详细描述
Objective
To investigate the therapeutic effects and short-term and long-term efficacy of high-intensity transcranial alternating current stimulation (Hi-tACS) on negative symptoms of schizophrenia.
Methods: A randomized controlled design was used, 60 schizophrenic patients who met the enrollment criteria were randomly assigned to either the Hi-tACS intervention group or the sham stimulation control group. Both groups continued their regular medication regimen. The intervention group received continuous current stimulation, while the control group received only 40 seconds of current stimulation per session. The treatment was administered twice daily (morning and afternoon) from Monday to Friday for 2 weeks, with each session lasting 40 minutes, for a total of 20 sessions. Negative symptoms, cognitive function, social function, and quality of life were assessed at baseline, 2 weeks, and 3 months post-intervention.
The primary outcome will be clinical symptoms, the secondary outcome will be the social function and quality of life, and the process measures included social cognition and neurocognition.
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, Outcomes Assessor)
盲法说明
In this study, the RAND function in Excel is used to generate a random number table to form the random group assignment sequence, which is simple randomization. Interventions are standardized by medical personnel who have passed a training test. Stimulation devices of two groups are identical in appearance. Blinding: The assessors, medical personnel and participants are blinded; the research coordinator assigned the enrolled schizophrenia patients to the Hi-tACS intervention group or the sham stimulation control group based on the randomization table. The assessors, medical personnel and participants are not informed of the treatment group assignments.
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
- •Han Chinese population;
- •Age ≥ 18 years;
- •Education level ≥ 6 years, able to fill out questionnaires on their own, and having sufficient audiovisual level to complete the necessary examinations;
- •Meets DSM-5 diagnostic criteria for schizophrenia as assessed by MINI 7.0;
- •Residual negative symptoms, with at least one item ≥2 on the negative subscale of PANSS (N1-N7);
- •Taking second-generation atypical antipsychotic medication, with no medication or dosage adjustments in the last two weeks
- •Patients and guardians agreed to participate in the study and signed an informed consent form.
排除标准
- •Meets DSM-5 diagnostic criteria for other mental disorders;
- •Total score ≥19 on the PANSS positive subscales (P1-P7) ;
- •Severe negative symptoms that prevent the patient from completing the required assessments and interventions;
- •Serious physical or central nervous system disease (intracranial infection, intracranial tumor, presence of metal objects in the skull; epilepsy, seizures; history of hydrocephalus or central nervous system tumors; with implanted electronic devices; serious cardiac disease and fitted with a pacemaker, etc.);
- •Impaired skin integrity at the site of electrode placement or hypersensitivity to electrode gels or adhesives;
- •Mental retardation (Wechsler Adult Intelligence Scale WAIS <70) and/or severe cognitive impairment (Brief Mental State Examination MMSE <24);
- •Presence of vision and/or hearing problems that prevent completion of relevant tests;
- •Alcohol or drug abuse/dependence;
- •Pregnancy;
- •Those who have participated or are participating in other clinical studies 3 months ago;
- •Failure or refusal to sign the informed consent form.
研究组 & 干预措施
intervention group
On the basis of maintaining regular medication, the intervention group received continuous Hi-tACS stimulation. The intervention was administered twice daily, in the morning and afternoon, from Monday to Friday for 2 weeks, with each session lasting 40 minutes, totaling 20 sessions.
干预措施: High-intensity transcranial alternating current stimulation (Hi-tACS) (Device)
control group
On the basis of maintaining regular medication, the control group received sham Hi-tACS stimulation, with each stimulation session lasting only 40 seconds. The intervention was administered twice daily, in the morning and afternoon, from Monday to Friday for 2 weeks, with each session lasting 40 minutes, totaling 20 sessions.
干预措施: Sham High-intensity transcranial alternating current stimulation (Sham-Hi-tACS) (Device)
结局指标
主要结局
Change in negative symptoms of schizophrenia
时间窗: change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3)
The primary efficacy evaluation measure is the Positive and Negative Syndrome Scale (PANSS), with statistical parameters including the PANSS total score and the negative subscale score. These scores reflect the severity of schizophrenia symptoms, with higher total or subscale scores indicate more severe symptoms. A decrease in scores after the intervention indicates symptom reduction and effective intervention.
次要结局
- Change in quality of life(change from baseline (W0) to 3 months after intervention (M3))
- Change in neuropsychological status of cognitive function(change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3))
- Change in social function(change from baseline (W0) to 3 months after intervention (M3))
- Change in sleep quality of clinical symptom(change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3))
- Change in depression of clinical symptom(change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3))
- Change in anxiety of clinical symptom(change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3))
- Change in theory of mind of social cognition(change from baseline (W0) to 3 months after intervention (M3))
- Change in emotion perception of social cognition(change from baseline (W0) to 3 months after intervention (M3))
- Change in EEG data of cognitive function(change between baseline (W0), the end of intervention at 2 weeks (W2) and 3 months after intervention (M3))
- Change in coping styles of social cognition(change from baseline (W0) to 3 months after intervention (M3))
- Change in attributional styles of social cognition(change from baseline (W0) to 3 months after intervention (M3))