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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real stimulation | Experimental | 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. |
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| Sham stimulation | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated theta burst stimulation | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renrong Wu, Prof | Contact | 15874179855 | wurenrong@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410000 | China |
The data will be provided for scientific study only with the permission of the principle investigator.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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Randomized Quadro-blind clinical trial
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The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.
| Sham stimulation | Device | 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. |
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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 |