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Not yet recruiting NCT07444463

Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Clinical Applications

No phase Interventional Schizophrenia Bipolar Disorder Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive transcranial magnetic stimulation (rTMS).
Who it may be relevant to
Registry conditions: Schizophrenia, Bipolar Disorder, Major Depressive Disorder (MDD). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment

Overview

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.

Interventions

  • Device repetitive transcranial magnetic stimulation (rTMS)
    Patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).

Primary outcome measures

  • Cognitive changes [Time frame: From enrollment to the end of treatment at 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Xiangya Hospital — Changsha

Identifiers

NCT: NCT07444463 · 20270101GWB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗