Targeted Intervention Study of DTMS on Impaired Insight in Early Psychosis
Key facts
- Who runs it
- Shanghai Mental Health Center
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 Jan 2024
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- active-dTMS
- sham-dTMS
- Record updated
- 24 December 2024
- Why it stopped
- Because this research is a modification of a previous study that was not obtained, and the intervention method has changed significantly, we are considering withdrawing this study and reapplying.
Who can take part
- Age
- 15 years to 35 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 14~35 years old
- 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
- 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
Who cannot take part
- Undergoing anti-psychotic medication for more than 2 weeks
- A pacemaker or other metal implants in the body, pregnancy, or claustrophobia
- Meeting the diagnostic criteria of psychotic disorders (including affective disorders)
- Threshold symptoms are induced by other mental disorders or psychoactive substances
- Being diagnosed as organic brain diseases, or severe somatic diseases
- Dementia, or mental retardation (IQ<70)
- Being a condition of scalp infection
- Participating in any other clinical intervention research
- Had Experienced traumatic brain injury, and got scores of 7
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 reflecting the function of self monitoring was a potential objective marker of impaired insight. And further functional magnetic resonance imaging (fMRI) analysis showed that the functional connectivity between anterior cingulate gyrus (ACC) and medial temporal gyrus (MTG) was related to insight. Studies have shown that ACC theta oscillation is the key to self monitoring, and theta-alpha phase synchronization between frontotemporal is closely related to cognition. Therefore, this project hypothesized that targeted regulation of ACC theta oscillations could promote theta-alpha phase synchronization and functional connectivity between ACC and MTG, thereby improving patients' insight. The first-episode and high-risk subjects were recruited to detect the theta oscillation of ACC, theta-Alpha phase synchronization and functional connectivity between ACC and MTG using EEG-fMRI. Deep transcranial magnetic stimulation was introduced to regulate ACC theta oscillations. The high-risk subjects were followed up for two years. It was estimated that the theta-alpha phase synchronization of ACC-MTG and insight in the active-dTMS group were significantly improved. And the outcome of the high-risk subjects is better. The project develops neuroregulatory techniques for impaired insight of schizophrenia and is expected to provide a solution for this clinical pain point.
The 4 groups in the trial
- active-CHRExisting treatment, for comparison
Participants will be intervened with deep transcranial magnetic stimulation (dTMS).
Treatment: active-dTMS
- sham-CHRSham treatment, for comparison
Participants, as a control group, will receive sham stimulation.
Treatment: sham-dTMS
- active-FESExisting treatment, for comparison
Patients with first-episode schizophrenia will be intervened with deep transcranial magnetic stimulation (dTMS).
Treatment: active-dTMS
- sham-FESSham treatment, for comparison
Patients with first-episode schizophrenia, as a control group, will receive sham stimulation.
Treatment: sham-dTMS
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Study on Targeted Intervention for Insight in Patients with First Episode and Clinical High Risk of Schizophrenia Based on Theta Oscillation in Anterior Cingulate Cortex
- Record updated
- 24 December 2024