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Transcranial Direct Current Stimulation (Tdcs) for Treatment of Major Depressive Disorder White paper Transcranial direct current stimulation (tDCS) for treatment of major depressive disorder Mode of action Brain stimulation with tDCS can be used to induce chang- In brief es in neuronal excitability in a polarity-dependent manner: positive anodal stimulus increases cortical excitability (de- • Non-invasive tDCS relieves symptoms in polarization) without triggering action potentials, whereas depressed patients by modulating cortical negative cathodal stimulus decreases excitability (hyperpo- excitability through a weak current larization)4 (Figure 1). To date, several studies have demon- strated hypoactivity of the left dorsolateral prefrontal cortex • tDCS can be used both as a monotherapy (DLPFC) in depressed patients.7,8 Accordingly, the antide- or as an adjunct to antidepressant pressant effects of tDCS may be due to the increased excit- medication and psychotherapy ability of the DLPFC, which further balances the left-right prefrontal activity and subsequently leads to symptom relief • Meta-analyses have found active tDCS in depressed patients.3 treatment to be significantly superior to sham tDCS in depressed patients Neurobiological studies have demonstrated that tDCS me- diates a cascade of events at a cellular and molecular level, • tDCS is well tolerated, and no serious including effects on the N-methyl-D-aspartate receptors.9,10 side effects have been reported In addition to acute transient membrane potential chang- es that can last up to one hour, tDCS is associated with longer-lasting synaptic changes.11–13 Further studies eluci- dating the detailed mechanism of tDCS in therapeutic neu- romodulation are currently ongoing. Major depressive disorder (MDD) has an estimated life- time prevalence of 8–12% and is associated with signifi- cant morbidity and mortality.1 Standard treatments for Cathodal Anodal MDD include psychological therapies and antidepressant electrode (-) electrode (+) medication, which are often only moderately effective and Decreased neuronal Increased neuronal may have adverse effects. Furthermore, the applicability of excitability at excitability at right DLPFC left DLPFC non-pharmacological brain stimulation options such as re- petitive transcranial magnetic stimulation (rTMS) or elec- troconvulsive therapy (ECT) are limited either by cost or 2,3 significant safety issues. Non-invasive transcranial direct A battery-powered device current stimulation (tDCS) is a safe, effective, and afforda- delivers a direct current ble therapeutic option for several psychiatric disorders.4 of 2mA for 30 minutes Importantly, tDCS can be used either as a monotherapy or as an adjunct to increase the effect of conventional antide- Figure 1. Mode of action. The neuromodulatory effect of tDCS is based pressant medication and psychotherapy.5,6 on a weak constant current delivered through electrodes. The positive stimulus from the anodal electrode increases neuronal excitability at the left DLPFC, which is found to be hypoactive in depressed patients. The current flows from the positive to the negative electrode, and balances the activity in the prefrontal cortex.4,14 tDCS for treatment of MDD 1 Method In agreement with the meta-analyses, an RCT of 120 pa- tients comparing the treatment efficacy of active vs. sham During the tDCS procedure, the patient remains awake tDCS, combined either with sertraline (50mg/day), a selec- and alert. A low-intensity, direct current of 2mA is applied tive serotonin reuptake inhibitor (SSRI), or placebo drug, directly to the scalp through saline-soaked electrodes (Fig- reported a significant reduction in the Montgomery–Ås- ure 1). The electrodes are placed on the scalp over the left berg Depression Rating Scale (MADRS) scores in patients and right DLPFC.14 This forms a circuit for the current treated with active tDCS vs. sham tDCS, regardless of ser- flow, which modulates neuronal excitability in the frontal traline administration.6 Analysis of the active tDCS+place- lobe. In addition to the polarity and location of the elec- bo vs. sham tDCS+sertraline groups revealed comparable trodes, the current intensity, stimulation duration, and the efficacies. Furthermore, the greatest efficacy was achieved electrode size affect the total charge delivered in the pro- in the active tDCS+sertraline group, and this effect was cedure.4 One daily session lasts typically 20 to 30 minutes, demonstrated to be additive. and the procedure is usually repeated up to 15 times dur- ing the acute treatment period.15,16 Response Meta-analysis of 259 patients demonstrated significantly higher response rates in active vs. sham tDCS (odds ratio, Efficacy and safety [OR] 1.63, 95% confidence interval, [CI] 1.26 to 2.12).14 Sim- ilar outcomes were observed in the RCT of 120 patients (Fig- The National Institute for Health and Care Excellence ure 3), where only 16.7% of the placebo group but 43.3% of (NICE) in the United Kingdom published interventional the patients treated with active tDCS (OR=8.6, 95% CI 2.5 to procedure guidance “Transcranial direct current stimula- 29.1, p<0.001) and 63.3% of active tDCS+sertraline-treated tion (tDCS) for depression” in August 2015. The guidance patients (OR=3.8, 95% CI 1.1 to 12.7, p=0.03) responded.6 is based on an interventional procedure overview of about Response was defined as >50% improvement in depression 2000 patients including a meta-analysis (consisting of sev- scores from baseline. en randomized control trials, RCTs), a systematic review, an open-label follow-up study, and a case report.15,16 Remission Significantly higher remission rates were reported in active Efficacy vs. sham tDCS in a meta-analysis of 259 patients (OR=2.50, A systematic review and meta-analysis of seven RCTs 95% CI 1.26 to 2.49).14 In the RCT of 120 patients, a signif- demonstrated a significantly greater improvement in pa- icantly larger number of active tDCS-treated patients also tients treated with active (n=137) vs. sham tDCS (n=122).14 achieved remission compared to sham tDCS (Figure 3).6 tDCS was used either as a monotherapy or an adjunct to Remission was defined either as a score <8 in the Hamilton conventional therapy in patients suffering from moder- Depression Rating Scale, or a score ≤10 in MADRS. ate-degree treatment-resistant depression. The relative strength of standardized treatment effects for each study is Relapse shown in Figure 2. A more recent meta-analysis published A mean response duration of 11.7 weeks was demonstrat- after the NICE guidance also demonstrated superior effica- ed in an open-label follow-up study of 42 patients who cy of active vs. sham tDCS in 393 patients.13 were responders in the initial study phase and continued to receive treatment. The sustained response rate at 24 weeks was 47% (95% CI 27 to 64). Lower sustained response rates were observed in patients with treatment-resistant depres- sion than in patients with non-refractory disease (10% vs. 77%, OR 5.52, p<0.01).17 Study % ID SMD (95% CI) weight Figure 2. Forest plot of effect sizes comparing Blumberger (2012) -0.13 (–0.94, 0.67) 11.14 active (n=137) vs. sham (n=122) tDCS-treat- Boggio (2008) 0.88 (0.09, 1.67) 11.42 ed patients. Meta-analysis of 259 depressed pa- Brunoni (2013) 0.64 (0.28, 1.01) 23.17 tients found active tDCS to be significantly su- Fregni (2006) 1.19 (0.16, 2.21) 7.92 perior to sham tDCS treatment. Hedges’ g was Loo (2010) –0.25 (–0.87, 0.37) 15.11 used as the measure of effect size to standardize different depression scales. The level of hetero- Loo (2012) 0.56 (0.06, 1.06) 18.63 geneity was not significant between the studies. Palm I (2012) 0.13 (–1.11, 1.38) 5.83 Figure is adapted from Shiozawa et al. (2014). Palm II (2012) –0.01 (-1.14, 1.12) 6.77 Abbreviations: SMD, standard mean deviation; Total 0.40 (0.07, 0.73) 100.00 CI, confidence interval. –2.21 0 2.21 favours sham tDCS favours active tDCS 2 tDCS for treatment of MDD Response rate Remission rate 70 50 46.7 63.3 60 40.0 40 50 43.3 30.0 30 40 33.3 30 20 16.7 13.3 20 10 Proportion of patients (%) 10 Proportion of patients (%) 0 0 + placebo + sertraline + placebo + sertraline + placebo + sertraline + placebo + sertraline sham tDCS active tDCS sham tDCS active tDCS Figure 3. Response and remission rates according to MADRS scores in active vs. sham-treated depressed patients (n=120). An RCT found significantly higher response (p<0.001) and remission (p=0.03) rates in active tDCS vs. sham tDCS-treated patient groups 6 weeks after treatment initiation. tDCS was combined with either sertraline (50mg/day) or placebo drug treatment. Response was defined as a MADRS score change >50% from baseline, and remission as a score ≤10. Data is adapted from Brunoni et al. (2013). Similarly, a follow-up study of initial responders (n=26) Sooma tDCS™ for treatment of MDD reported cumulative probabilities of disease remission to be 83.7% at 3 months (maintenance tDCS once weekly) Sooma offers a fixed tDCS procedure that is indicated for and 51.1% at 6 months (maintenance tDCS once every two adult patients suffering from unipolar depression. Sooma weeks). This study also found medication resistance to be tDCS™ is easy-to-use and cost-effective, which makes it the only predictor of relapse during maintenance tDCS ideal for routine clinical practice. This system can be used treatment (hazard ratio, [HR]=1.61, 95% CI 1.10 to 2.36, as a monotherapy or as an adjunct to conventional treat- p<0.05).18 ments such as antidepressant medication and psychother- apy. Importantly, it is a viable option for patients who do Acceptability not tolerate or benefit from antidepressant medication.
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