Using deep transcranial magnetic stimulation to improve insight in high-risk individuals for schizophrenia

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

This study is testing if a brain stimulation treatment can help people at high risk for schizophrenia better understand their condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 15 Years to 35 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06831877 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of deep transcranial magnetic stimulation (dTMS) on enhancing insight in individuals at clinical high risk for psychosis and those experiencing first-episode schizophrenia. It employs a randomized, double-blind, sham-controlled design, administering dTMS over 10 consecutive days with two sessions each day. Participants will be assessed before, immediately after, and at one and three months post-intervention to evaluate changes in insight and the potential predictive role of insight on schizophrenia outcomes. The study aims to understand how modulating brain activity in specific regions can improve clinical insight.

Who should consider this trial

Good fit: Ideal candidates include individuals meeting the criteria for clinical high risk for psychosis or those diagnosed with schizophrenia who exhibit impaired insight.

Not a fit: Patients with established psychotic disorders or those participating in other clinical intervention research may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance insight in high-risk individuals, potentially reducing the conversion rate to schizophrenia.

How similar studies have performed: While the approach of using dTMS for this specific purpose is novel, previous studies have shown promise in using similar techniques for other neurological and psychiatric conditions.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lihua Xu, Doctoral

Conditions Impaired Insight; Insight; Self monitoring; Anterior cingulate cortex; Medial prefrontal cortex; Deep transcranial magnetic stimulation