active-dTMS: The dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
sham-dTMS: The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
Study summary
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 with various disorders. Therefore, this project targets mPFC/ACC and uses deep transcranial magnetic stimulation (dTMS) for targeted modulation, with an exploratory observation of changes in patients' insight before and after neurostimulation.
Eligibility
Sex
ALL
Min age
15 Years
Max age
35 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical Insight — Baseline and immediately after the intervention Clinical insight will be assessed using the SAI (Schedule for Assessment of Insight). The SAI is a semi-structured interview tool consisting of seven items, with a total score of 14. It evaluates three areas: illness recognition (scoring 0-6), relabeling of symptoms (scoring 0-4), and treatment compliance (scoring 0-4). Patients are considered to have impaired insight if they score less than 3 on illness recognition, less than 2 on relabeling of symptoms, and less than 2 on treatment compliance.
Trial sites (1)
Facility
City
Region
Status
Shanghai Mental Health Center
Shanghai
Shanghai Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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