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| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
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The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS stimulation | Experimental | The participants randomized into experimental group will receive iTBS stimulation of dlPFC 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 intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 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 |
|---|---|---|---|---|
| iTBS | Device | Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Appetite | Three-Factor Eating Questionnaire | Change from Baseline to 6days and 36days |
| Change of MCCB | The MATRICS™ Consensus Cognitive Battery | Change from Baseline to 6days and 36days |
| Change of ERP | Food picture ERP recorded by EEG | Change from Baseline to 6days and 36days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of fasting glucose | in mmol/l | Change from Baseline to 6days and 36days |
| Change of fasting insulin level | in mmol/l | Change from Baseline to 6days and 36days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renrong Wu, Prof | Central South University Psychiatry Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central South University | Changsha | Hunan | 410000 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
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| Shame stimulation | Device | TMS coil vertical to the brain surface, with same protocol as iTBS |
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| Change of Triglyceride | in mmol/l | Change from Baseline to 6days and 36days |
| Change of Total Cholesterol | in mmol/l | Change from Baseline to 6days and 36days |
| Change of LDL | in mmol/l | Change from Baseline to 6days and 36days |
| Change of HDL | in mmol/l | Change from Baseline to 6days and 36days |
| Change of BMI | weight and height will be combined to report BMI in kg/m^2 | Change from Baseline to 6days and 36days |