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Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight

RecruitingNAAges 15 Years - 35 YearsAllShanghai Mental Health Center
NCT06831877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Impaired insight is a key factor in the conversion of high-risk individuals to schizophrenia, but there is a lack of targeted interventions. We found that an electroencephalogram (EEG) signal, error-related negativity (ERN), was closely related to impaired insight. The more pronounced the ERN attenuation in patients with high-risk and first-episode psychosis, the more severe the impairement of clinical insight. ERN is a negative potential that appears at the frontal and central scalp electrode locations within 100 ms after an erroneous behavioral response, reflecting the activity of the brain's error-monitoring system. Research has shown that the brain region underlying ERN is partly located in the anterior cingulate cortex (ACC). Other research has reported that the activity extending from the ACC to the medial prefrontal cortex (mPFC) is associated with impaired insight in patients wit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Meet the criteria of clinical high risk for psychosis or meet the DSM-V diagnostic criteria for schizophrenia; * Meeting the following definition of impaired insight: below a specific threshold in at least one dimension of the Scale to Assess Unawareness of Mental Disorder (SAI). Specifically, a score of less than 2 in the "awareness of the need for treatment" dimension, less than 3 in the "recognition of illness" dimension, or less than 2 in the "attribution of psychotic symptoms" dimension qualifies an individual as having impaired insight; * Having completed at least six years of primary education; * Being able to give informed consent, oral or written. Patients under 18 years old give oral consent and their next of kin or legal guardians give written consent. Exclusion Criteria: * Participating in any other clinical intervention research; * Meeting the diagnostic criteria of psychotic disorders (including affective disorders); * Threshold symptoms are induced by other mental disorders or psychoactive substances; * Undergoing anti-psychotic medication for more than 2 weeks; * Being diagnosed as organic brain diseases, or severe somatic diseases; * Had Experienced traumatic brain injury, and got scores of 7; * Dementia, or mental retardation (IQ\<70); * Being a condition of scalp infection; * A pacemaker or other metal implants in the body, pregnancy, or claustrophobia.
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What it tests

  • active-dTMS
  • sham-dTMS
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Where

1 site
Shanghai Mental Health Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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