rTMS on Appetite and Cognitive Function in Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Device: iTBSDevice: Shame stimulation
- Registration Number
- NCT04714970
- Lead Sponsor
- Central South University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Patients with schizophrenia in accordance with DSM-5
- Commorbid with significant weight gain after antipsychotics
- Informed Consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iTBS stimulation iTBS 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. Sham stimulation Shame stimulation 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.
- Primary Outcome Measures
Name Time Method Change of Appetite Change from Baseline to 6days and 36days Three-Factor Eating Questionnaire
Change of MCCB Change from Baseline to 6days and 36days The MATRICS™ Consensus Cognitive Battery
Change of ERP Change from Baseline to 6days and 36days Food picture ERP recorded by EEG
- Secondary Outcome Measures
Name Time Method Change of fasting insulin level Change from Baseline to 6days and 36days in mmol/l
Change of fasting glucose Change from Baseline to 6days and 36days in mmol/l
Change of Triglyceride Change from Baseline to 6days and 36days in mmol/l
Change of Total Cholesterol Change from Baseline to 6days and 36days in mmol/l
Change of LDL Change from Baseline to 6days and 36days in mmol/l
Change of HDL Change from Baseline to 6days and 36days in mmol/l
Change of BMI Change from Baseline to 6days and 36days weight and height will be combined to report BMI in kg/m\^2
Trial Locations
- Locations (1)
Central South University
🇨🇳Changsha, Hunan, China