Actively Recruiting

Phase Not Applicable
Age: 15Years - 35Years
All Genders
NCT06831877

Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight

Led by Shanghai Mental Health Center · Updated on 2025-02-18

138

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight

Who Can Participate

Age: 15Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet criteria for clinical high risk for psychosis or diagnosis of schizophrenia by DSM-V
  • Impaired insight defined by specific low scores on the Scale to Assess Unawareness of Mental Disorder (SAI)
  • Completed at least six years of primary education
  • Able to provide informed consent (oral consent for those under 18, with written consent from guardians)
Not Eligible

You will not qualify if you...

  • Currently participating in other clinical intervention studies
  • Diagnosed with psychotic disorders including affective disorders
  • Psychotic symptoms caused by other mental disorders or psychoactive substances
  • On antipsychotic medication for more than 2 weeks
  • Diagnosed with organic brain diseases or severe physical illnesses
  • History of traumatic brain injury with a score of 7
  • Diagnosis of dementia or intellectual disability (IQ below 70)
  • Scalp infections
  • Presence of pacemaker, metal implants, pregnancy, or claustrophobia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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Research Team

L

Lihua Xu, Doctoral

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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