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

Thais Rabanea-Souza, Sheila M C Cirigola, Cristiano Noto, July S Gomes, Caroline C Azevedo, Ary Gadelha, Quirino Cordeiro, Álvaro M Dias, Acioly L T Lacerda, Thais Rabanea-Souza, Sheila M C Cirigola, Cristiano Noto, July S Gomes, Caroline C Azevedo, Ary Gadelha, Quirino Cordeiro, Álvaro M Dias, Acioly L T Lacerda

Abstract

Background: Cognitive deficits are core symptoms of schizophrenia that occur from the early stages of the disorder. There is reliable evidence that cognitive deficits are associated with outcomes in schizophrenia; thus, early treatment could be particularly important. Studies with different neuromodulation techniques involving subjects with schizophrenia suggest 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 ameliorate positive, negative, and cognitive symptoms. 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/design: Seventy patients in the early stages of psychosis will be randomly allocated to receive 20 min of active 2-mA tDCS or sham stimulation once a day for 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 baseline and at 1 and 3 months following the end of the intervention (sustained effect).

Discussion: The development and utilization of potentially effective neuroenhancement tools such as the non-invasive brain stimulation technique tDCS for the treatment and rehabilitation of cognitive impairment in the early stages of schizophrenia may contribute to improving outcomes of the disorder and eventually provide a further understanding of the nature of the complex and dynamic neural processes underlying those abnormalities.

Trial registration: ClinicalTrials.gov, NCT03071484 . Registered on 7 March 2017.

Keywords: Cognitive symptomatology; Double-blind randomized controlled trial; Early stages of psychosis; Neuromodulation; Neuropsychology; Schizophrenia; Transcranial direct current stimulation.

Conflict of interest statement

Ethics approval and consent to participate

This study protocol, version 2.0, was approved by the Ethics Committee of the Federal University of Sao Paulo, in Sao Paulo, Brazil (CEP N°1220/2016), and a written informed consent will be obtained from all participants in the trial.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of the trial interventions and assessments
Fig. 2
Fig. 2
Flowchart of the trial

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