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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lihua Xu, Doctoral
• Email: mas_xulihua2008@163.com
• Phone: 15000092086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.