Schizophrenia TreAtment with electRic Transcranial Stimulation (STARTS): design, rationale and objectives of a randomized, double-blinded, sham-controlled trial

Abstract

Introduction Schizophrenia is a severe mental disorder. While some antipsychotic medications have demonstrated efficacy in treating positive symptoms, there is no widely recognized treatment for negative symptoms, which can cause significant distress and impairment for patients with schizophrenia. Here we describe the rationale and design of the STARTS study (Schizophrenia TreAtment with electRic Transcranial Stimulation), a clinical trial aimed to test the efficacy of a non-pharmacological treatment known as transcranial direct current stimulation (tDCS) for treating the negative symptoms of schizophrenia Methods The STARTS study is designed as a randomized, sham-controlled, double-blinded trial evaluating tDCS for the treatment of the negative symptoms of schizophrenia. One-hundred patients will be enrolled and submitted to 10 tDCS sessions over the left dorsolateral prefrontal cortex (anodal stimulation) and left temporoparietal junction (cathodal stimulation) over 5 consecutive days. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in the Positive and Negative Syndrome Scale (PANSS) negative subscale score over time and across groups. Biological markers, including blood neurotrophins and interleukins, genetic polymorphisms, and motor cortical excitability, will also be assessed. Results The clinical results will provide insights about tDCS as a treatment for the negative symptoms of schizophrenia, and the biomarker investigation will contribute towards an improved understanding of the tDCS mechanisms of action. Conclusion Our results could introduce a novel therapeutic technique for the negative symptoms of schizophrenia. Clinical trial registration: ClinicalTrials.gov, NCT02535676 .

Efficacy and safety of Transcranial Direct Current Stimulation (tDCS) on Cognitive Function in Chronic Schizophrenia with Tardive Dyskinesia (TD): a randomized, double-blind, sham-controlled, clinical trial

“…Conversely, in an earlier randomized controlled study [39] , the total cognitive function scores, working memory, and attentional alertness scores of patients treated with tDCS were signi cantly higher than those in the pseudo-stimulus group. Similarly, previous studies [40,41] have shown that tDCS can improve the patient's working memory ability when using the left dorsolateral prefrontal cortex as an anode stimulation point. These results are inconsistent with this research.…”

Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia

“…We used opaque, sealed envelopes for allocation concealment. The study protocol was described elsewhere and performed with no significant changes (Supplement 1).…”

“…The following stimulation parameters were used: 2 mA; 5 × 7 cm 2 electrodes, with the anode centered over the area corresponding to the left dorsolateral PFC and the cathode centered over the area corresponding to the left temporoparietal junction; and use of the electroencephalography 10–20 system (F3 and T3P3 areas, respectively), with both electrodes’ large axes (7 cm) perpendicular to the skull’s circumference. Computational simulation of the current distribution can be found elsewhere …”