Exploratory Intervention Study of dTMS on Impaired Insight in Early Psychosis
Study Details
Study Description
Brief Summary
In psychiatry, insight refers to the ability of patients to recognize their abnormal mental experiences and seek treatment actively. Impaired insight is one of the key factors in the development of schizophrenia, which determines the clinical outcome and functional prognosis. Based on previous literatures and the applicant's research, the hypothesis was proposed that the neural circuit of medial prefrontal cortex (MPFC)-precuneus/posterior cingulate cortex (PC/PCC), involving in the self-referential tasks, is the core circuit of impaired insight in psychosis. This project intends to recruit patients with clinical high-risk for psychosis, with vary degree of impaired insight, and introduces deep transcranial magnetic stimulation (dTMS) to regulate MPFC activity. Meanwhile, reality-monitoring ability under eye movement tracker will be tested. Furthermore, magnetic resonance imaging (MRI) will be used to observe resting-state functional connectivity of MPFC-PC/PCC. This study will provide new evidence for its precise intervention targets.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The study will conduct randomized and controlled experimental design, including deep transcranial magnetic stimulation (dTMS) and sham stimulation (SH-dTMS). Each included participant will be given informed consent and then randomly assigned to different montage of stimulation. Participants are blind to the dTMS montage. Researchers in this study will include clinical evaluators, laboratory inspectors, dTMS operators, and statistical analysts. Before unblinding, each group of researchers will have no access to the information collected by the other groups. For example, except the dTMS operators, no one knows which stimulus montage any of the participants receive. 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. Clinical assessments and laboratory tests will be administered at baseline, at the end of the last session, and at the three-month node after the end of dTMS treatment. After the three-month observation, first stage unblinding will be conducted. At this moment, dTMS operators will provide the groups of A and B, but no corresponding montage, to the statistical analysts. After analyzing the differences between the two groups, second stage unblinding will be performed and the results of the clinical trial will be further analyzed by revealing the corresponding stimulus montage of each group. This study will be implemented at a single center, the Shanghai Mental Health Center (SMHC).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: active-CHR Participants will be intervened with deep transcranial magnetic stimulation (dTMS). |
Device: active-dTMS
The dTMS using H-coil with 20Hz stimulate mPFC. 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.
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| Sham Comparator: sham-CHR Participants, as a control group, will receive sham stimulation. |
Device: 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.
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Outcome Measures
Primary Outcome Measures
- Change in clinical insight [Baseline, five days, One month and three month]
Clinical insight will be assessed using SAI. SAI is a semi-structured interview tools including seven items, with a total score of 14, 0-6 for recognition of illness, 0-4 for relabeling of psychotic phenomena, and 0-4 for treatment compliance. Patients, with less than 3 scores on recognition of illness, 2 on relabeling of psychotic phenomena, and 2 on treatment compliance, are considered to be improved on insight.
- Change in cognitive insight [Baseline, five days, One month and three month]
Cognitive insight will be assessed using BCIS. BCIS, developed by Beck et al., is a self-report questionnaire with 15 items. BCIS includes two subscales: Self-Reflectiveness (SR) and Self-Certainty (SC). The total score of BCIS is calculated from the score of SR minus that of SC, which is referred to as the composite cognitive insight index (CCII). When participants scores 10 or above on CCII, it indicates that they have good cognitive insight.
Secondary Outcome Measures
- Change in psychopathological symptoms [Baseline, five days, One month, three month and six month]
This study will also observe the psychopathological symptoms, including positive, negative and general symptoms, using PANSS.The reductive ratio of PANSS points will be calculated after dTMS treatment.
- Covariant change of clinical insight and psychopathological symptoms [Baseline, five days, One month, three month and six month]
Clinical insight will be assessed using SAI, and the psychopathological symptoms will be measured using PANSS. The correlation of psychopathological symptoms with clinical insight will be analyzed, especially possible covariant change after dTMS treatment.
- Covariant change of cognitive insight and psychopathological symptoms [Baseline, five days, One month, three month and six month]
Cognitive insight will be assessed using BCIS, and the psychopathological symptoms will be measured using PANSS. The correlation of psychopathological symptoms with cognitive insight will be analyzed, especially possible covariant change after dTMS treatment.
- Change in reality monitoring ability [Baseline, One month and three month]
Reality monitoring ability refers to distinguish internally self-generated information from externally-derived information. The test will be carried out by the experimental paradigm of reality monitoring ability.The stimulus materials are easy to be accepted and understood by patients with mental illness.The material consisted of 48 pairs of familiar pictures and was divided into two tests, each consisting of a learning and a testing phase. In the learning phase, 24 pictures will be presented with different combinations of conditions (four combinations of "perceptive/imaginative × left/right" conditions). In the testing phase, one object will be presented and the participants will be asked to decide whether the other paired object is perceptive or imaginative, or whether the image is positioned on the left or right side of the screen.
- Change in Resting-state functional brain connectivity [Baseline and three month]
Imaging data will be collected on a 3-T Siemens Magnetom Verio syngo MR B17 scanner and a 32-channel head coil, including structural phase and resting stage detection, which will be used to analyze the functional connection between MPFC and PC/PCC.
- Convertion rate of transition into psychosis [Six month]
This study will use SIPS to identify individuals with CHR and assess the participants' clinical outcomes, including transition into psychosis, symptomatic, remission, and other disorders
Eligibility Criteria
Criteria
Inclusion Criteria:
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14~35 years old;
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Fulfilling the criteria of clinical high risk for psychosis (CHR-P);
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Meeting the following definition of impaired insight;
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Having completed at least six years of primary education;
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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:
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Participating in any other clinical intervention research;
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Meeting the diagnostic criteria of psychotic disorders (including affective disorders);
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Threshold symptoms are induced by other mental disorders or psychoactive substances;
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Undergoing anti-psychotic medication for more than 1 week;
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Being diagnosed as organic brain diseases, or severe somatic diseases;
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Had Experienced traumatic brain injury, and got scores of 7;
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Dementia, or mental retardation (IQ<70);
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Being a condition of scalp infection;
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A pacemaker or other metal implants in the body, pregnancy, or claustrophobia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Mental Health Center | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- Shanghai Mental Health Center
Investigators
- Study Chair: Jijun Wang, Doctoral, Shanghai Mental Health Center
- Study Director: Tianhong Zhang, Doctoral, Shanghai Mental Health Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200805