Home-Based Transcranial Direct Current Stimulation for the Treatment of Symptoms of Depression and Anxiety in Temporal Lobe Epilepsy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial

Suelen Mandelli Mota, Luiza Amaral de Castro, Patrícia Gabriela Riedel, Carolina Machado Torres, José Augusto Bragatti, Rosane Brondani, Thais Leite Secchi, Paulo Roberto Stefani Sanches, Wolnei Caumo, Marino Muxfeldt Bianchin, Suelen Mandelli Mota, Luiza Amaral de Castro, Patrícia Gabriela Riedel, Carolina Machado Torres, José Augusto Bragatti, Rosane Brondani, Thais Leite Secchi, Paulo Roberto Stefani Sanches, Wolnei Caumo, Marino Muxfeldt Bianchin

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].

Keywords: anxiety; depression; epilepsy; neuromodulation; non-pharmacological interventions; tDCS – transcranial direct current stimulation.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Mota, Amaral de Castro, Riedel, Torres, Bragatti, Brondani, Secchi, Sanches, Caumo and Bianchin.

Figures

FIGURE 1
FIGURE 1
Each arrow corresponds to a 30-day period, except the last (1-year follow up). Patients self-administered 20 sessions of tDCS at home during 20 min daily (20 tDCS), 5 days a week for 4 weeks. Next, three maintenance consecutive weekly sessions (WS) of tDCS’s were applied in the research laboratory. To assess the frequency of seizures, patients filled in seizure reports during a month prior to the start of treatment and kept a seizure diary from day one to day 60 of the study. Participants were evaluated on days 1, 15, 30, 60, and after 1-year follow up of the study using the Beck Depression Inventory II (BDI II). The Inventory for Quality of Life in Epilepsy (QOLIE-31) was evaluated on days 1, 30, 60 and after 1-year follow up. The Hamilton Anxiety Scale (HAM-A) were applied only on days 1, 30 and 60.
FIGURE 2
FIGURE 2
Assessment of depressive symptoms in the Sham and Active groups (using the Beck II Depression Inventory - BDI-II) during five stages (i) pre-treatment; (ii) after 10 sessions of tDCS; (iii) after 20 daily sessions, and (iv) after 1 month of follow-up performing tDCS once a week for 3 weeks; (v) 1 year after treatment. Data arereported as mean +SD score on the BDI-II scale. Data analysis was performed using the Generalized Estimating Equations model (GEE). There was no statistically significant difference between groups considering the type of treatment.
FIGURE 3
FIGURE 3
Quality of life assessment in the Sham and Active groups using the Epilepsy Quality of Life Inventory (QOLIE-31) in three stages: (i) pre-treatment; (ii) after 20 daily sessions; (iii) after 1 month performing tDCS once a week for 3 weeks. Data are reported as mean +SD QOLIE-31 score. Data analysis was performed using the Generalized Estimation Equations (GEE) model. There was no statistically significant difference between groups considering the type of treatment.
FIGURE 4
FIGURE 4
Anxiety symptoms assessed in the active tDCS and Sham groups using the Hamilton Anxiety Scale (HAM-A) in three stages: (i) pre-treatment; (ii) after 20 daily sessions; (iii) after 1 month of follow-up, performing tDCS once a week for 3 weeks. Data are reported as mean +SD. Data analysis was performed using the Generalized Estimation Equations (GEE) model. There was no statistically significant difference between groups considering the type of treatment.

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