Schizophrenia, Metabolic Disturbance, Eating Behavior, Transcranial Magnetic Stimulation
Conditions
Keywords
schizophrenia, metabolic disturbance, cTBS, Event related potentials
Brief summary
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.
Interventions
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).
DEVICESham stimulation
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.
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.
Intervention model description
Randomized Quadro-blind clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of body weight | from baseline to 6 weeks | the change of participants weight |
| Change of body mass index | from baseline to 6 weeks | the change of participants BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barrat impulsiveness scale | from baseline to 6 weeks | four domains regarding impulsiveness, from 26-104 higher score means higher impulse. |
| Positive and Negative syndrome rating scale | from baseline to 6 weeks | Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms. |
| Food picture stimulation Event-related potentials | from baseline to 6 weeks | 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. |
| Self-Control Scale | from baseline to 6 weeks | five domains regarding self control ability, from 36-180 higher score means better self control. |
| Three Factor Eating Questionnaire | from baseline to 6 weeks | three domain regarding eating behavior, from 0-51, higher score means better. |
Countries
China
Contacts
Primary ContactRenrong Wu, Prof
Outcome results
None listed