rTMS on Appetite and Cognitive Function in Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: iTBS
* Device: Shame stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with schizophrenia in accordance with DSM-5 Commorbid with significant weight gain after antipsychotics Informed Consent Exclusion Criteria: Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before Drug or alcohol abuse Pregnant or lactating Contraindication to rTMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iTBS stimulation<br>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. | Device: iTBS<br>* 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.<br>|
| Sham Comparator: Sham stimulation<br>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. | Device: Shame stimulation<br>* TMS coil vertical to the brain surface, with same protocol as iTBS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, Schizophrenia, Appetite, Cognitive Function