Abstract
We conducted a double-blind randomized clinical trial in order to examine the effects and the safety of home-based transcranial direct current stimulation (tDCS) on depressive and anxious symptoms of patients with temporal lobe epilepsy (TLE). We evaluated 26 adults with TLE and depressive symptoms randomized into two different groups: active tDCS (tDCSa) and Sham (tDCSs). The patients were first submitted to 20 sessions of tDCS for 20 min daily, 5 days a week for 4 weeks and then received a maintenance tDCS application in the research laboratory once a week for 3 weeks. The intensity of the current was 2 mA, applied bilaterally over the dorsolateral prefrontal cortex, with the anode positioned on the left side and the cathode on the right side. Participants were evaluated on days 1, 15, 30, and 60 of the study using the Beck Depression Inventory II (BDI). A follow-up evaluation was performed 1 year after the end of treatment. They were also evaluated for quality of life and for anxious symptoms as secondary outcomes. The groups did not differ in clinical, socioeconomic or psychometric characteristics at the initial assessment. There was no statistically significant difference between groups regarding reported adverse effects, seizure frequency or dropouts. On average, between the 1st and 60th day, the BDI score decreased by 43.93% in the active group and by 44.67% in the Sham group (ΔBDIfinal – initial = −12.54 vs. −12.20, p = 0.68). The similar improvement in depressive symptoms observed in both groups was attributed to placebo effect and interaction between participants and research group and not to tDCS intervention per se. In our study, tDCS was safe and well tolerated, but it was not effective in reducing depressive or anxiety symptoms in patients with temporal lobe epilepsy.Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT03871842].
Highlights
Temporal lobe epilepsy (TLE) is one of the most frequent forms of focal epilepsy and is associated with high rates of neuropsychiatric disorders (Bragatti et al, 2011)
Depressive and anxiety disorders can impair the quality of life of patients with epilepsy (PWE) and can increase adverse events related to the use of antiepileptic drugs (AEDs) (Kanner et al, 2012; Kwon and Park, 2014)
Considering that a longer treatment time can produce better results in depressive and anxiety symptoms (Padberg et al, 2017; de Lima et al, 2019) and that, according to clinical and experimental evidence, conventional models of Transcranial Direct Current Stimulation (tDCS) are not associated with the generation of epilepsy crises (Bikson et al, 2016; Liu et al, 2016), we propose to expand the treatment of depressive symptoms of patients with TLE using 23 sessions of bimodal home-based tDCS
Summary
Temporal lobe epilepsy (TLE) is one of the most frequent forms of focal epilepsy and is associated with high rates of neuropsychiatric disorders (Bragatti et al, 2011). Some studies on tDCS in the treatment of depressive disorder and anxiety have used the anodal stimulation protocol over the left DLPFC, with the cathode electrode positioned over the right DLPFC, with 2mA intensity, for 20 to 30 min a day for 5 to 30 days (Boggio et al, 2008; Loo et al, 2012; Stein et al, 2020). Considering that a longer treatment time can produce better results in depressive and anxiety symptoms (Padberg et al, 2017; de Lima et al, 2019) and that, according to clinical and experimental evidence, conventional models of tDCS are not associated with the generation of epilepsy crises (Bikson et al, 2016; Liu et al, 2016), we propose to expand the treatment of depressive symptoms of patients with TLE using 23 sessions of bimodal home-based tDCS (anode positioned over the left DLPFC and cathode over the right DLPFC).
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