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

Sponsor
Central South University
Study ID
NCT07444463
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 3, 2026
Start date
Jan 1, 2027
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

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

Central Contacts

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