Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial
Abstract Background Transcranial direct current stimulation (tDCS) is a promising treatment for major depressive disorder (MDD). This study evaluated its antidepressant and cognitive effects as a safe, effective, home-based therapy for MDD. Methods This double-blind, sham-controlled, randomized...
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| Language: | English |
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Cambridge University Press
2025-01-01
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| Series: | European Psychiatry |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S092493382401811X/type/journal_article |
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| author | CW Lee K Park JE Ahn Y Jang YS Park H Yu D Lee HK Ihm J Lee J Kim YI Lee S-E Lim SS Kwon HY Park TH Ha I-Y Yoon Woojae Myung Ji Hyun Baek |
| author_facet | CW Lee K Park JE Ahn Y Jang YS Park H Yu D Lee HK Ihm J Lee J Kim YI Lee S-E Lim SS Kwon HY Park TH Ha I-Y Yoon Woojae Myung Ji Hyun Baek |
| author_sort | CW Lee |
| collection | DOAJ |
| description |
Abstract
Background
Transcranial direct current stimulation (tDCS) is a promising treatment for major depressive disorder (MDD). This study evaluated its antidepressant and cognitive effects as a safe, effective, home-based therapy for MDD.
Methods
This double-blind, sham-controlled, randomized trial divided participants into low-intensity (1 mA, n = 47), high-intensity (2 mA, n = 49), and sham (n = 45) groups, receiving 42 daily tDCS sessions, including weekends and holidays, targeting the dorsolateral prefrontal cortex for 30 minutes. Assessments were conducted at baseline and weeks 2, 4, and 6. The primary outcome was cognitive improvement assessed by changes in total accuracy on the 2-back test from baseline to week 6. Secondary outcomes included changes in depressive symptoms (HAM-D), anxiety (HAM-A), and quality of life (QLES). Adverse events were monitored. This trial was registered with ClinicalTrials.gov (NCT04709952).
Results
In the tDCS study, of 141 participants (102 [72.3%] women; mean age 35.7 years, standard deviation 12.7), 95 completed the trial. Mean changes in the total accuracy scores from baseline to week 6 were compared across the three groups using an F-test. Linear mixed-effects models examined the interaction of group and time. Results showed no significant differences among groups in cognitive or depressive outcomes at week 6. Active groups experienced more mild adverse events compared to sham but had similar rates of severe adverse events and dropout.
Conclusions
Home-based tDCS for MDD demonstrated no evidence of effectiveness but was safe and well-tolerated. Further research is needed to address the technical limitations, evaluate broader cognitive functions, and extend durations to evaluate its therapeutic potential.
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| format | Article |
| id | doaj-art-2764da5939a141ee9101f094d03be67f |
| institution | Kabale University |
| issn | 0924-9338 1778-3585 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | European Psychiatry |
| spelling | doaj-art-2764da5939a141ee9101f094d03be67f2025-01-23T05:42:21ZengCambridge University PressEuropean Psychiatry0924-93381778-35852025-01-016810.1192/j.eurpsy.2024.1811Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trialCW Lee0K Park1https://orcid.org/0009-0009-7508-1099JE Ahn2https://orcid.org/0009-0003-7778-4704Y Jang3https://orcid.org/0000-0003-1922-9246YS Park4https://orcid.org/0000-0003-1228-4250H Yu5https://orcid.org/0000-0002-1070-1092D Lee6https://orcid.org/0000-0003-2215-5647HK Ihm7https://orcid.org/0000-0002-8242-7440J Lee8J Kim9YI Lee10https://orcid.org/0000-0001-8810-1225S-E Lim11https://orcid.org/0009-0008-8474-6892SS Kwon12https://orcid.org/0000-0002-3191-0563HY Park13TH Ha14https://orcid.org/0000-0002-2778-6619I-Y Yoon15Woojae Myung16https://orcid.org/0000-0001-9985-2032Ji Hyun Baek17https://orcid.org/0000-0002-1366-0396Department of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaCenter for Clinical Research, Samsung Biomedical Research Institute (SBRI), Seoul, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Department of Health Science and Technology, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, South KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaCenter for Neuroscience Imaging Research, Institute of Basic Science (IBS), Suwon, Republic of KoreaYbrain Inc., Sungnam, Republic of KoreaYbrain Inc., Sungnam, Republic of KoreaCenter of Excellence on Mood Disorders, Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USADepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Psychiatry, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Republic of Korea Abstract Background Transcranial direct current stimulation (tDCS) is a promising treatment for major depressive disorder (MDD). This study evaluated its antidepressant and cognitive effects as a safe, effective, home-based therapy for MDD. Methods This double-blind, sham-controlled, randomized trial divided participants into low-intensity (1 mA, n = 47), high-intensity (2 mA, n = 49), and sham (n = 45) groups, receiving 42 daily tDCS sessions, including weekends and holidays, targeting the dorsolateral prefrontal cortex for 30 minutes. Assessments were conducted at baseline and weeks 2, 4, and 6. The primary outcome was cognitive improvement assessed by changes in total accuracy on the 2-back test from baseline to week 6. Secondary outcomes included changes in depressive symptoms (HAM-D), anxiety (HAM-A), and quality of life (QLES). Adverse events were monitored. This trial was registered with ClinicalTrials.gov (NCT04709952). Results In the tDCS study, of 141 participants (102 [72.3%] women; mean age 35.7 years, standard deviation 12.7), 95 completed the trial. Mean changes in the total accuracy scores from baseline to week 6 were compared across the three groups using an F-test. Linear mixed-effects models examined the interaction of group and time. Results showed no significant differences among groups in cognitive or depressive outcomes at week 6. Active groups experienced more mild adverse events compared to sham but had similar rates of severe adverse events and dropout. Conclusions Home-based tDCS for MDD demonstrated no evidence of effectiveness but was safe and well-tolerated. Further research is needed to address the technical limitations, evaluate broader cognitive functions, and extend durations to evaluate its therapeutic potential. https://www.cambridge.org/core/product/identifier/S092493382401811X/type/journal_articleadjunctive home-based therapyanxietycognitionmajor depressive disordertranscranial direct current stimulation |
| spellingShingle | CW Lee K Park JE Ahn Y Jang YS Park H Yu D Lee HK Ihm J Lee J Kim YI Lee S-E Lim SS Kwon HY Park TH Ha I-Y Yoon Woojae Myung Ji Hyun Baek Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial European Psychiatry adjunctive home-based therapy anxiety cognition major depressive disorder transcranial direct current stimulation |
| title | Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial |
| title_full | Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial |
| title_fullStr | Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial |
| title_full_unstemmed | Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial |
| title_short | Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial |
| title_sort | efficacy and safety of home based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder a double blind randomized multi site clinical trial |
| topic | adjunctive home-based therapy anxiety cognition major depressive disorder transcranial direct current stimulation |
| url | https://www.cambridge.org/core/product/identifier/S092493382401811X/type/journal_article |
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