Clinical trial of treatment with Transcranial Magnetic Stimulation (brain stimulation) in negative symptoms of Schizophrenia
- Conditions
- SchizophreniaF02.418
- Registration Number
- RBR-8w4bjf8
- Lead Sponsor
- niversidade Federal de São Paulo (UNIFESP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Individuals diagnosed with Schizophrenia (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM 5); aged 18 to 50; both genders; presenting with moderate intensity negative symptoms; capable of reading and understanding Portuguese; with stable use of medications and no changes in antipsychotics in the last three months; not using anticonvulsant medications; not having abused drugs or alcohol in the past year; not having undergone any brain stimulation protocols in the past year before admission to the study
Individuals diagnosed with depression or substance abuse dependency, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); diagnosed neurological disorders (epilepsy and history of seizures, traumatic brain injury); presence of metallic implants in the brain region (pacemakers, cochlear implants, implanted electrodes/stimulators, aneurysm clips/coils, stents)
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to observe a 20% reduction in scores on the five sub-domains of negative symptoms evaluated by the Brief Negative Symptom Scale (BNSS) in patients diagnosed with Schizophrenia
- Secondary Outcome Measures
Name Time Method To investigate the effectiveness of the intervention for Schizophrenia symptoms, assessed by the reduction in the total score of the Positive and Negative Syndrome Scale (PANSS);To investigate the association between aspects of sleep (subjective quality, insomnia, and hypersomnia), daytime sleepiness, and their relationship with negative symptoms, through the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale;To assess the impact of the intervention on a global measure of executive function through the MATRICS Consensus Cognitive Battery (MCCB);Examine the association of heart rate variability (HRV) in relation to the protocol, through resting heart rate assessed by a heart rate monitor, and its relationship with negative symptoms