Study on Deep Transcranial Magnetic Stimulation for Enhancing Insight
NCT ID: NCT06831877
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2023-12-01
2026-09-30
Brief Summary
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Detailed Description
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1. Modulating ACC Functional Activity Using dTMS to Observe Changes in Insight Among FES and CHR Before and After Intervention This study will employ a randomized, double-blind, sham-controlled experimental design. dTMS intervention will be administered for 10 consecutive days, with two sessions per day, ensuring at least a 3-hour interval between sessions. A total of 36 FES participants and 68 CHR participants with impaired insight will be recruited. Participants will be randomly assigned to either the active-dTMS group or the sham-dTMS group to compare changes in insight between the two conditions. This study will conduct clinical assessments and laboratory testing before and immediately after the intervention. Additionally, clinical assessments will be performed at one month and three months post-intervention to analyze the sustained effects of dTMS in modulating ACC functional activity to improve insight.
2. Follow-Up of CHR Participants to Analyze the Predictive Role of Insight and ACC Functional Activity on CHR Outcomes A prospective cohort design will be used to compare the transition outcomes among three CHR groups: the active-dTMS group, the sham-dTMS group, and an observational control group. The primary focus is to examine the probability of conversion to schizophrenia at a one-year follow-up and to analyze the extent to which insight and ACC functional activity predict CHR outcomes. 34 CHR participants with intact insight (observational control group) will be recruited for baseline assessments and laboratory testing, followed by a one-year follow-up. By comparing baseline assessments, laboratory indicators, and clinical outcomes between the observational control group and the CHR intervention groups (active-dTMS and sham-dTMS), this study aims to determine whether improvement in insight in the active-dTMS group leads to prognostic outcomes comparable to those of the observational control group. Specifically, it will assess whether the risk of conversion to schizophrenia in the active-dTMS group becomes statistically indistinguishable from that of the observational control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
After the post-intervention assessments, the first stage of unblinding will take place. At this stage, dTMS operators will provide group identifiers (A and B) to the statistical analysts, but without revealing the corresponding stimulation montages. Once the statistical analysis of group differences is completed, a second stage of unblinding will occur, allowing for further analysis of the clinical trial results, with the corresponding stimulation montage revealed for each group.
Study Groups
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active-CHR
Individuals with clinical high risk for psychosis (CHR) will be intervened with dTMS.
active-dTMS
The dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
sham-CHR
Individuals with CHR, as a control group, will receive sham stimulation.
sham-dTMS
The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
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.
No interventions assigned to this group
active-FEP
Patients with first-episode psychosis (FEP) will be intervened with dTMS.
active-dTMS
The dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
sham-FEP
FEP patients , as a control group, will receive sham stimulation.
sham-dTMS
The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
Interventions
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active-dTMS
The dTMS using H-coil with 5Hz stimulate ACC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
sham-dTMS
The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
35 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Jijun Wang
Role: STUDY_DIRECTOR
Shanghai Mental Health Center
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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dTMS and Insight
Identifier Type: -
Identifier Source: org_study_id
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