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
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...
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| Vydáno v: | Frontiers in integrative neuroscience Ročník 15; s. 753995 |
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Frontiers Research Foundation
08.12.2021
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| 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]. |
|---|---|
| AbstractList | 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]. 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].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]. 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, = 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 . 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. [ClinicalTrials.gov], identifier [NCT03871842]. 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]. We conduced 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 minutes 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 2mA, 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 reduce depressive or anxiety symptoms in patients with temporal lobe epilepsy. ClinicalTrials.gov Identifier: NCT03871842 |
| Author | Bragatti, José Augusto Brondani, Rosane Bianchin, Marino Muxfeldt Torres, Carolina Machado Amaral de Castro, Luiza Mota, Suelen Mandelli Riedel, Patrícia Gabriela Caumo, Wolnei Secchi, Thais Leite Sanches, Paulo Roberto Stefani |
| AuthorAffiliation | 1 Programa de Pós-Graduação em Ciências Médicas, Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil 4 Laboratório de Engenharia Biomédica, Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil 5 Laboratório de Dor & Neuromodulação, Hospital de Clínicas de Porto Alegre , Porto Alegre , Brazil 2 Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil 3 Centro para Tratamento de Epilepsia Refratária (CETER), Basic Research and Advanced Investigations in Neuroscience (BRAIN), Serviço de Neurologia do Hospital de Clínicas de Porto Alegre , Porto Alegre , Brazil |
| AuthorAffiliation_xml | – name: 4 Laboratório de Engenharia Biomédica, Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil – name: 1 Programa de Pós-Graduação em Ciências Médicas, Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil – name: 2 Universidade Federal do Rio Grande do Sul , Porto Alegre , Brazil – name: 3 Centro para Tratamento de Epilepsia Refratária (CETER), Basic Research and Advanced Investigations in Neuroscience (BRAIN), Serviço de Neurologia do Hospital de Clínicas de Porto Alegre , Porto Alegre , Brazil – name: 5 Laboratório de Dor & Neuromodulação, Hospital de Clínicas de Porto Alegre , Porto Alegre , Brazil |
| Author_xml | – sequence: 1 givenname: Suelen Mandelli surname: Mota fullname: Mota, Suelen Mandelli – sequence: 2 givenname: Luiza surname: Amaral de Castro fullname: Amaral de Castro, Luiza – sequence: 3 givenname: Patrícia Gabriela surname: Riedel fullname: Riedel, Patrícia Gabriela – sequence: 4 givenname: Carolina Machado surname: Torres fullname: Torres, Carolina Machado – sequence: 5 givenname: José Augusto surname: Bragatti fullname: Bragatti, José Augusto – sequence: 6 givenname: Rosane surname: Brondani fullname: Brondani, Rosane – sequence: 7 givenname: Thais Leite surname: Secchi fullname: Secchi, Thais Leite – sequence: 8 givenname: Paulo Roberto Stefani surname: Sanches fullname: Sanches, Paulo Roberto Stefani – sequence: 9 givenname: Wolnei surname: Caumo fullname: Caumo, Wolnei – sequence: 10 givenname: Marino Muxfeldt surname: Bianchin fullname: Bianchin, Marino Muxfeldt |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34955774$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1111_epi_17514 crossref_primary_10_1097_MD_0000000000030220 crossref_primary_10_1186_s40814_023_01423_x crossref_primary_10_1016_j_ctim_2025_103142 crossref_primary_10_1016_j_yebeh_2025_110290 crossref_primary_10_3389_fneur_2024_1462364 crossref_primary_10_3389_fpsyt_2024_1335243 crossref_primary_10_1007_s00406_023_01620_y crossref_primary_10_1001_jamanetworkopen_2025_16459 |
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| ContentType | Journal Article |
| Copyright | Copyright © 2021 Mota, Amaral de Castro, Riedel, Torres, Bragatti, Brondani, Secchi, Sanches, Caumo and Bianchin. 2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Copyright © 2021 Mota, Amaral de Castro, Riedel, Torres, Bragatti, Brondani, Secchi, Sanches, Caumo and Bianchin. 2021 Mota, Amaral de Castro, Riedel, Torres, Bragatti, Brondani, Secchi, Sanches, Caumo and Bianchin |
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| Keywords | epilepsy neuromodulation non-pharmacological interventions anxiety depression tDCS – transcranial direct current stimulation |
| Language | English |
| License | Copyright © 2021 Mota, Amaral de Castro, Riedel, Torres, Bragatti, Brondani, Secchi, Sanches, Caumo and Bianchin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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