Targeted Intervention Study of Deep Transcranial Magnetic Stimulation for Impaired Insight in Patients with High-Risk and First-Episode Psychosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Lihua Xu, Doctoral
mas_xulihua2008@163.com
15000092086
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 138
Treatments
Active_comparator: active-CHR
Individuals with clinical high risk for psychosis (CHR) will be intervened with dTMS.
Sham_comparator: sham-CHR
Individuals with CHR, as a control group, will receive sham stimulation.
No_intervention: NoI-CHR
For the observation group of CHR, baseline assessments will be conducted, and follow-up outcomes will be observed one year later. Clinical outcomes will be compared with those of the CHR intervention group.
Active_comparator: active-FEP
Patients with first-episode psychosis (FEP) will be intervened with dTMS.
Sham_comparator: sham-FEP
FEP patients , as a control group, will receive sham stimulation.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov