Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight

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.

NCT Number	NCT06831877
Lead Sponsor	Shanghai Mental Health Center
Conditions	Impaired Insight
Enrollment	138 participants
Start Date	2023-12-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-02-18