Schizophrenia
Conditions
Interventions
This is a study composed by two trials to evaluate the effects of non-pharmacological techniques to cognitive improvement in schizophrenia:
1)Transcranial Direct Current Stimulation (tDCS): a paralle
anode placed over the left dorsolateral prefrontal cortex, and the cathode contralaterally, following the 10/20 EEG system. The stimulation is performed for 10 days, over two consecutive weeks (Monday
For the active stimulation, the following parameters were used: 2mA of tDCS applied for 20 minutes with electrodes of 25cm2 wrapped in cotton material soaked in saline solution. For the sham stimulati
Device
Behavioural
Other
E02.331.750
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects between 18 to 65 years old diagnosed with schizophrenia; No history of substance abuse/dependence, in exception to tobacco and/or caffeine; No diagnosis of any neurological conditions (e.g. Parkinson’s disease); (d) No history of seizures; No unexplained loss of consciousness; Stability of pharmacological treatment for at least 6 weeks; No contraindications to tDCS, such as metal in the head or implanted brain medical devices; No pregnancy at enrollment; acceptance to participate in the study and provide the written informed consent.
Exclusion criteria
Exclusion criteria: Subjects with psychiatric diagnoses other than schizophrenia, except bu the health controls; Subjects with schizophrenia with predominant positive symptoms; Subject illiterate or unable to complete the cognitive assessment; IQ < 70; Clinically relevant suicide risk. Dropout was considered after absence in two consecutive tDCS sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intended outcome: differences in MATRICS total score, comparing the baseline, after and follow-up measures.;Observed outcome: difference in working memory composite score, measured by the Brazilian version of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MATRICS). It was compared the baseline, after and follow-up measures. Observed results: no differences were observed for working memory after tDCS, through time*group analysis (p=0.720, IC: 95%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Intended outcome: (1) Positive and Negative Syndrome Scale (PANSS) (2) Calgary Depression Scale (3) Global Assessment of Functioning Scale (GAF) The data measured in the 3 time-points will be analyzed using ANOVA, test with a 95% confidence interval.;Observed outcome: Performance in the other cognitive domains from MATRICS battery: (1) Speed of processing: Trail Making Test: Part A (TMTA), Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding and Category Fluency Test: Animal naming (Fluency); (2) Attention: Continuous Performance Test—Identical Pairs (CPT-IP); (3) Verbal learning: Hopkins Verbal Learning Test—Revised (HVLT-R); (4) Visual learning: Brief Visuospatial Memory Test—Revised (BVMT-R); (5) Reasoning and problems solving: Neuropsychological Assessment Battery (NAB): Mazes; For schizophrenia patients, clinical assessment were used as secondary outcome: (1) Positive and Negative Syndrome Scale (PANSS) (2) Calgary Depression Scale (3) Global Assessment of Functioning Scale (GAF) All cognitive and clinical scores were analysed according to the following description: The scores measure in the 3 time-points were analyzed using generalized estimating equations (GEE) (using normal distribution, a robust estimator as covariance matrix and exchangeable correlation matrix structure). Post-hoc pairwise comparisons were run using Bonferroni adjustment for multiple comparisons. Confidence interval: 95% There was no differences for any cognitive outcome: (1) Speed of processing (p=0.306); (2) Attention/ vigilance (p=.0139); (3) Verbal Learning (p=0.696); (4) Visual Learning (p=0.891); (5) Reasoning and problem solving (p=0.154); Clinical outcomes: there was no differences for: Calgary (p=0.354) GAF (p=0.318) PANSS, positive subscale (p=0.687). There was improvement in the following subscales: PANSS negative subscale (p<0.001) PANSS general subscale (p<0.011) PANSS total subscale (p<0.001) | — |
Countries
Brazil
Contacts
Public ContactJuly Gomes
Universidade Federal de São Paulo
Outcome results
None listed