Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment
| Registry | NCT07444463 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 400 (Estimated) |
| Sponsor | Central South University (Other) |
| Conditions | Schizophrenia, Bipolar Disorder, Major Depressive Disorder (MDD) |
| Interventions | repetitive transcranial magnetic stimulation (rTMS) (Device) |
| Dates | start 2027-01-01 (estimated), primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-03-03, last updated 2026-03-04 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia All trials for Bipolar Disorder All trials of repetitive transcranial magnetic stimulation (rTMS)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients with schizophrenia | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) | 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. |
| Patients with bipolar disorder | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) | 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. |
| Patients with major depressive disorder | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS) | 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. |
| healthy controls | No intervention | 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. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Second Xiangya Hospital | Changsha, Hunan | China |