Schizophrenia
Conditions
Interventions
This is a double-blind, randomized, sham-controlled clinical study. The assessments will be conducted at baseline, T1 (intervention followed by reassessment), and T2 (30-day follow-up). Active group:
E02.621.820
Sponsors
Universidade Federal de São Paulo (UNIFESP)
Universidade Federal de São Paulo (UNIFESP)
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactIvan Taiar
Universidade Federal de São Paulo (UNIFESP)
Outcome results
None listed