Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Study Overview
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Brief Summary
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cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

Official Title
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The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia

Conditions
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Schizophrenia, Metabolic Disturbance, Eating Behavior, Transcranial Magnetic Stimulation

Intervention / Treatment
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* Device: accelerated theta burst stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with schizophrenia in accordance with DSM-5 BMI over 24 Accepting antipsychotics stable treatment for more then 2 months 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Quadro-blind clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real stimulation<br>Participants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area. | Device: accelerated theta burst stimulation<br>* cTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s).<br>|
| Sham Comparator: Sham stimulation<br>Participants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group. | Device: Sham stimulation<br>* Similar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight | the change of participants weight | from baseline to 6 weeks | 
| Change of body mass index | the change of participants BMI | from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative syndrome rating scale | Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms. | from baseline to 6 weeks | 
| Three Factor Eating Questionnaire | three domain regarding eating behavior, from 0-51, higher score means better. | from baseline to 6 weeks | 
| Barrat impulsiveness scale | four domains regarding impulsiveness, from 26-104 higher score means higher impulse. | from baseline to 6 weeks | 
| Self-Control Scale | five domains regarding self control ability, from 36-180 higher score means better self control. | from baseline to 6 weeks | 
| Food picture stimulation Event-related potentials | Several components of event-related potentials were analyzed regarding various cognitive processes. The data were analyzed using previously widely used pipelines to extract the characters of ERP components, for example, P3 and LPP, and compare its difference within groups and between groups through time. ERP analysis will be conducted using EEGLAB and FieldTrip in MATLAB, and statistic analysis will be conducted using R studio and SPSS. | from baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, metabolic disturbance, cTBS, Event related potentials