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| Name | Class |
|---|---|
| Federal University of SĆ£o Paulo | OTHER |
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Background: Cognitive deficits are a core symptom of schizophrenia even at the early stages of psychosis. To date, there has been reliable evidence that cognitive deficits are associated with outcomes in schizophrenia and early treatment could help to reduce the prominent disabling cognitive symptomatology which most schizophrenia patients still experience persistently. Outcomes in studies of repetitive transcranial magnetic stimulation in schizophrenia patients suggest the possibility that application of transcranial direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect positive and negative symptoms, respectively. Positive effects of tDCS have also been reported on cognitive symptoms. The present study protocol hypothesis is that the development and utilization of potentially effective neuroenhancement tools such as a non-invasive brain stimulation technique like tDCS for the treatment and rehabilitation of cognitive impairment in early stages of Schizophrenia may contribute to the elucidation of the nature of the complex and dynamic processes in the brain during the early stages of the disease, and may lead to a better outcome.
Objectives: The aim of the present study protocol is to evaluate the efficacy of tDCS in the treatment of cognitive symptomatology in the early stages of psychosis.
Methods: Sixty patients in the early stages of psychosis will be randomly allocated to receive 20 minutes of active 2-mA tDCS or sham stimulation once a day on 10 consecutive weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left temporo-parietal cortex. Neuropsychological and psychiatric assessments will be performed at the time of consent (baseline), at 1 and 3 months following the end of the intervention (maintenance effect).
The design of the present study protocol is a double-blind placebo controlled randomised clinical trial.
After being randomly allocated, the experimental group will receive a 20 minutes of active 2-mA tDCS once a day on 10 consecutive weekdays. The control group will receive a sham stimulation (placebo), which chosen parameters consists in after 40 seconds of real stimulation (2 mA), only a small current pulse occurred every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period.
Neuropsychological and psychiatric assessments will be performed at the time of consent (baseline), and at 1 and 3 months following the end of the intervention (maintenance effect). The primary outcome will be cognitive function and the second outcomes will be the positive and negative symptoms. Outcome assessments will be performed by trial research staff. Primary and second outcomes assessors (neuropsychologists and psychiatrists) and patients will be blinded to randomized allocation after assignment to interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | After being randomly allocated, the experimental group will receive a 20 minutes of active 2-mA tDCS once a day on 10 consecutive weekdays. |
|
| Sham - tDCS | Placebo Comparator | The control group will receive a sham stimulation, which chosen parameters consists in after 40 seconds of real stimulation (2 mA), only a small current pulse occurred every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | The tDCS is a non-invasive neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. |
| Measure | Description | Time Frame |
|---|---|---|
| MCCB⢠MATRICS⢠(Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery | A consensus cognitive battery for measuring cognition in schizophrenia, | 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Symptoms Scale (PANSS) | Positive and Negative Symptoms Scale (PANSS) | 3 months follow up |
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Inclusion Criteria:
The inclusion criteria include:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lacerda, MD, PhD | Contact | +55 19 38639438 | acioly@institutosinapse.org |
| Name | Affiliation | Role |
|---|---|---|
| Rabanea-Souza, MsC | Federal University of SĆ£o Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Interdisciplinary Clinical Neurosciences, Department of Psychiatry, Federal University of Sao Paulo | Recruiting | SĆ£o Paulo | 04039-032 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30953544 | Derived | Rabanea-Souza T, Cirigola SMC, Noto C, Gomes JS, Azevedo CC, Gadelha A, Cordeiro Q, Dias AM, Lacerda ALT. Evaluation of the efficacy of transcranial direct current stimulation in the treatment of cognitive symptomatology in the early stages of psychosis: study protocol for a double-blind randomized controlled trial. Trials. 2019 Apr 5;20(1):199. doi: 10.1186/s13063-019-3288-5. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |