Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cognitive changes
研究概览
简要总结
Previous and our studies have shown that cognitive impairments are core symptoms of three major psychiatric disorders-schizophrenia, bipolar disorder, and major depressive disorder, and are associated with underlying brain dysfunction. However, the specific brain networks involved in cognitive impairments (cognitive impairment brain networks) in these disorders, as well as whether their neuroimaging features can be applied to cognitive assessment, diagnosis, and precision treatment, remain unclear. This study aims to identify cognitive impairment brain networks using publicly available large-scale datasets and clinical research, and to explore whether the neuroimaging features of these networks can be utilized for cognitive assessment, diagnosis, and treatment response prediction. First, a "sensitive cognitive assessment model for major psychiatric disorders" will be established through meta-analysis based on sensitive scales. Second, cognitive impairment brain networks will be identified using publicly available large-scale datasets combined with the lesion network mapping method, and their validity will be examined by assessing their non-randomness, reproducibility, symptom specificity, and disease specificity. Third, cognitive assessment and diagnostic models will be developed based on neuroimaging features of these networks. Finally, a combination of cross-sectional and longitudinal study designs will be used in a clinical trial to validate the identified networks and models, and a treatment response prediction model will be established based on the neuroimaging features of cognitive impairment brain networks. This study will advance the understanding of the neurophysiological mechanisms underlying cognitive impairment in major psychiatric disorders, promote the application of neuroimaging in psychiatric diagnosis and treatment, and improve traditional diagnostic, therapeutic, and cognitive assessment approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1, For Patients (SZ, BD, MDD):
- •Diagnosis of schizophrenia (SZ), bipolar disorder (BD), or major depressive disorder (MDD) according to standard diagnostic criteria
- •First-episode drug-naïve patients or patients who have relapsed after discontinuing medication for more than one month
- •Aged 18-60 years
- •Completion of at least 6 years of formal education
- •2, For Healthy Controls:
- •Aged 18-60 years
- •Completion of at least 6 years of formal education
- •No current or past psychiatric disorders
- •No first-degree relatives with psychiatric disorders
- •No history of treatment with psychotropic medications or physical therapy for psychiatric disorders
排除标准
- •Prior use of psychotropic medications or receipt of physical treatment for psychiatric disorders (for patient group)
- •Contraindications to MRI scanning
- •History of brain injury
- •History of substance abuse
- •Presence of other neurological disorders
- •Presence of severe medical or systemic physical illnesses.
研究组 & 干预措施
Patients with schizophrenia
One hundred patients with schizophrenia (SZ) who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled.
Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans.
After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
Patients with bipolar disorder
One hundred patients with bipolar disorder who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled.
Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans.
After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
Patients with major depressive disorder
One hundred patients with major depressive disorder who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled.
Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans.
After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.
干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)
healthy controls
One hundred healthy controls will be enrolled. Before the baseline assessment, all participants will undergo demographic and clinical evaluations, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. Healthy controls will undergo clinical assessments and MRI scans at corresponding time points without receiving rTMS treatment.
结局指标
主要结局
Cognitive changes
时间窗: From enrollment to the end of treatment at 8 weeks
Cognitive Changes Assessed with the MATRICS Consensus Cognitive Battery (MCCB) after Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention
次要结局
未报告次要终点
研究者
Guo Wenbin
Professor
Central South University