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

Valiengo, Leandro; Gordon, Pedro Caldana; Carvalho, Juliana Barbosa de; Rı́os, Rosa M.; Koebe, Stephanie; Bilt, Martinus van de; Lacerda, Acioly Luiz Tavares de; Elkis, Hélio; Gattaz, Wagner F.; Brunoni, André R.

doi:10.1590/2237-6089-2018-0047

Cited by 5 publications

(4 citation statements)

References 51 publications

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“…Conversely, in an earlier randomized controlled study [ 43 ], the total cognitive function scores, working memory, and attentional alertness scores of patients treated with tDCS were significantly higher than those in the pseudo-stimulus group. Similarly, previous studies [ 44 , 45 ] have shown that tDCS can improve the patient’s working memory when using the left dorsolateral prefrontal cortex as an anode stimulation point. These results are inconsistent with this research.…”

Section: Discussionsupporting

confidence: 60%

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

Zhou,

Xia,

Zhao

et al. 2023

BMC Psychiatry

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Objective Previous studies have shown that transcranial direct current stimulation(tDCS) led to an improvement of cognitive function in patients with schizophrenia, but rare study has explored the effect of tDCS on long-term hospitalized chronic schizophrenia with tardive dyskinesia (TD). The present research explored if cognitive function in patients with long-term hospitalized chronic schizophrenia with TD could be improved through tDCS. Methods This study is a randomized, double-blind, sham-controlled clinical trial. Of the 52 patients, 14 dropped out, and 38 completed the experiment. Thirty-eight patients on stable treatment regimens were randomly assigned to receive active tDCS(n = 21) or sham stimulation(n = 17) on weekdays of the first, third, and fifth weeks of treatment. Patients performed the Pattern Recognition Memory (PRM) and the Intra/Extradimensional Set Shift (IED) from the Cambridge Neuropsychological Test Automated Battery (CANTAB) at baseline and the end of week 3, week 5. Clinical symptoms were also measured at the baseline and the fifth week using the Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS). Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment. Results There were no significant differences in PRM and IED performance metrics, SANS total score and PANSS total score between active and sham tDCS groups at the end of week 5 (p > 0.05). Furthermore, there was a significant difference in the adverse effects of the tingling sensation between the two groups (p < 0.05), but there was no significant difference in other side effects (p > 0.05). Conclusion According to these findings, no evidence supports using anodal stimulation over the left dorsolateral prefrontal cortex to improve cognitive function in patients with long-term hospitalized chronic schizophrenia with TD.

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Section: Discussionsupporting

confidence: 60%

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

Zhou,

Xia,

Zhao

et al. 2023

BMC Psychiatry

View full text Add to dashboard Cite

show abstract

“…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.…”

Section: Discussionsupporting

confidence: 58%

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

Zhou

Xia

Zhao

et al. 2023

Preprint

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Objective Previous studies have shown that transcranial direct current stimulation(tDCS) led to an improvement of cognitive function in patinets with schizophrenia, but rare study has explored the effect of tDCS on long-term hospitalized chronic schizophrenia with tardive dyskinesia(TD). The present research explored if cognitive function in patients with long-term hospitalized chronic schizophrenia with TD could be improved through tDCS. Methods This study is a randomized, double-blind, sham-controlled clinical trial. Of the 52 patients, 14 dropped out and 38 completed the experiment. Thirty-eight patients on stable treatment regimens were randomly assigned to receive active tDCS(n = 21) or sham stimulation(n = 17) on weekdays of the first, third, and fifth weeks of treatment. Patients performed the Pattern Recognition Memory(PRM) and the Intra/Extradimensional Set Shift (IED) from the Cambridge Neuropsychological Test Automated Battery at baseline, at the 3-week of tDCS treatment (week3), and the end of tDCS treatment (week5). Clinical symptoms were also measured at the baseline and the fifth week using the Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS).Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment. Results There were no significant differences in PRM and IED performance metrics, SANS total score and PANSS total score between active and sham tDCS groups at the end of the 5-wk treatment period (all P > 0.05).Furthermore, it was significant difference in the adverse effects of the tingling sensation between the two groups (P < 0.05), but there was no significant difference in other side effects (P > 0.05). Conclusion According to these findings, there is no evidence in support of the use of anodal stimulationover the left dorsolateral prefrontal cortex an approach for improving cognitive function in patients with long-term hospitalized chronic schizophrenia with TD.

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

Section: Methodsmentioning

confidence: 99%

“…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 …”

Section: Methodsmentioning

confidence: 99%

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

et al. 2020

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IMPORTANCE Negative symptoms represent a substantial burden in schizophrenia. Although preliminary studies have suggested that transcranial direct current stimulation (tDCS) is effective for some clusters of symptoms, the clinical benefits for negative symptoms are unclear.OBJECTIVE To determine the efficacy and safety of tDCS vs sham as an add-on treatment for patients with schizophrenia and predominant negative symptoms. DESIGN, SETTING, AND PARTICIPANTS The double-blind Schizophrenia Treatment With Electric Transcranial Stimulation (STARTS) randomized clinical trial was conducted from September 2014 to March 2018 in 2 outpatient clinics in the state of São Paulo, Brazil. Patients with schizophrenia with stable negative and positive symptoms and a minimum score of 20 points in the negative symptoms subscale of the Positive and Negative Syndrome Scale (PANSS) were included. INTERVENTIONS Ten sessions of tDCS performed twice a day for 5 days or a sham procedure. The anode and the cathode were positioned over the left prefrontal cortex and the left temporoparietal junction, respectively. MAIN OUTCOMES AND MEASURESChange in the PANSS negative symptoms subscale score at week 6 was the primary outcome. Patients were followed-up for an additional 6 weeks. RESULTSOf the 100 included patients, 20 (20.0%) were female, and the mean (SD) age was 35.3 (9.3) years. A total of 95 patients (95.0%) finished the trial. In the intention-to-treat analysis, patients receiving active tDCS showed a significantly greater improvement in PANSS score compared with those receiving the sham procedure (difference, 2.65; 95% CI, 1.51-3.79; number needed to treat, 3.18; 95% CI, 2.12-6.99; P < .001). Response rates for negative symptoms (20% improvement or greater) were also higher in the active group (20 of 50 [40%]) vs the sham group (2 of 50 [4%]) (P < .001). These effects persisted at follow-up. Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).CONCLUSIONS AND RELEVANCE Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.

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

Cited by 5 publications

References 51 publications

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

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

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

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

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