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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
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cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTBS stimulation | Experimental | The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. |
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| Sham stimulation | Sham Comparator | The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial magnetic stimulation | Device | transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Three-Factor Eating Questionnaire | min value 21, max value 84. The higher scores mean more unhealthy eating behavior. | Change from Baseline to 6days and 36days |
| MCCB | The MATRICS™ Consensus Cognitive Battery | Change from Baseline to 6days and 36days |
| The positive and negative syndrome scale | min score 30, max score 210. The higher score means more severe symptoms. | Change from Baseline to 6days and 36days |
| BMI | body mass index | Change from Baseline to 6days and 36days |
| Measure | Description | Time Frame |
|---|---|---|
| Resting EEG | resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated. | Change from Baseline to 6days and 36days |
| fasting glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central South University | Changsha | Hunan | 410000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38272892 | Derived | Kang D, Song C, Peng X, Yu G, Yang Y, Chen C, Long Y, Shao P, Wu R. The effect of continuous theta burst stimulation on antipsychotic-induced weight gain in first-episode drug-naive individuals with schizophrenia: a double-blind, randomized, sham-controlled feasibility trial. Transl Psychiatry. 2024 Jan 25;14(1):61. doi: 10.1038/s41398-024-02770-w. | |
| 37921353 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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1 group for intervention and 1 group for sham stimulation
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The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.
| sham stimulation | Device | TMS coil vertical to the brain surface, with same protocol as cTBS |
|
in mmol/l
| Change from Baseline to 6days and 36days |
| Triglyceride | in mmol/l | Change from Baseline to 6days and 36days |
| Total Cholesterol | in mmol/l | Change from Baseline to 6days and 36days |
| Low Density Lipoprotein | in mmol/l | Change from Baseline to 6days and 36days |
| High Density Lipoprotein | in mmol/l | Change from Baseline to 6days and 36days |
| Kang D, Zhang Y, Wu G, Song C, Peng X, Long Y, Yu G, Tang H, Gui Y, Wang Q, Yuan T, Wu R. The Effect of Accelerated Continuous Theta Burst Stimulation on Weight Loss in Overweight Individuals With Schizophrenia: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. Schizophr Bull. 2024 Apr 30;50(3):589-599. doi: 10.1093/schbul/sbad144. |