Efficacy and Safety of tDCS and tACS in Treatment of Major Depressive Disorder: A Randomized, Double-Blind, Factorial Placebo-Controlled Study Design

References

• Huang Y, Wang Y, Wang H, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019;6(3):211–224. doi:10.1016/S2215-0366(18)30511-X30792114
   PubMed Web of Science ®Google Scholar
• Rush AJ. Limitations in efficacy of antidepressant monotherapy. J Clin Psychiatry. 2007;68(10):8–10.
   Google Scholar
• John Rush A, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. J Am J Psychiatry. 2006;163(11):1905–1917. doi:10.1176/ajp.2006.163.11.1905
   Web of Science ®Google Scholar
• Brunoni AR, Boggio PS, Ferrucci R, Priori A, Fregni F. Transcranial direct current stimulation: challenges, opportunities, and impact on psychiatry and neurorehabilitation. Front Psychiatry. 2013;4:19. doi:10.3389/fpsyt.2013.0001923544030
   PubMedGoogle Scholar
• Yamada Y, Sumiyoshi T. Neurobiological mechanisms of transcranial direct current stimulation for psychiatric disorders; neurophysiological, chemical, and anatomical considerations. Front Hum Neurosci. 2021;15:631838. doi:10.3389/fnhum.2021.63183833613218
   PubMed Web of Science ®Google Scholar
• Lefaucheur JP, Antal A, Ayache SS, et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017;128(1):56–92.27866120
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Vanderhasselt MA. Working memory improvement with non-invasive brain stimulation of the dorsolateral prefrontal cortex: a systematic review and meta-analysis. Brain Cogn. 2014;86:1–9. doi:10.1016/j.bandc.2014.01.00824514153
   PubMed Web of Science ®Google Scholar
• Ironside M, O’Shea J, Cowen PJ, Harmer CJ. Frontal cortex stimulation reduces vigilance to threat: implications for the treatment of depression and anxiety. Biol Psychiatry. 2016;79(10):823–830. doi:10.1016/j.biopsych.2015.06.01226210058
   PubMed Web of Science ®Google Scholar
• Brennan S, Mcloughlin DM, O’Connell R, et al. Anodal transcranial direct current stimulation of the left dorsolateral prefrontal cortex enhances emotion recognition in depressed patients and controls. J Clin Exp Neuropsychol. 2017;39(4):1–12. doi:10.1080/13803395.2016.123059527829324
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Tortella G, Bensenor IM, Lotufo PA, Carvalho AF, Fregni F. Cognitive effects of transcranial direct current stimulation in depression: results from the SELECT-TDCS trial and insights for further clinical trials. J Affect Disord. 2016;202:46–52.27253216
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Moffa AH, Fregni F, et al. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. British j Psychiatry. 2016;208(6):522–531. doi:10.1192/bjp.bp.115.164715
   PubMed Web of Science ®Google Scholar
• Shiozawa P, Fregni F, Benseñor IM, et al. Transcranial direct current stimulation for major depression: an updated systematic review and meta-analysis. Int J Neuropsychopharmacol. 2014;17(9):1443–1452. doi:10.1017/S146114571400041824713139
   PubMed Web of Science ®Google Scholar
• Chew T, Ho KA, Loo CK. Inter- and intra-individual variability in response to transcranial direct current stimulation (tDCS) at varying current intensities. Brain Stimul. 2015;8(6):1130–1137. doi:10.1016/j.brs.2015.07.03126294061
   PubMed Web of Science ®Google Scholar
• Esmaeilpour Z, Shereen AD, Ghobadi-Azbari P, et al. Methodology for tDCS integration with fMRI. Hum Brain Mapp. 2020;41(7):1950–1967. doi:10.1002/hbm.2490831872943
   PubMed Web of Science ®Google Scholar
• Kambeitz J, Goerigk S, Gattaz W, et al. Clinical patterns differentially predict response to transcranial direct current stimulation (tDCS) and escitalopram in major depression: a machine learning analysis of the ELECT-TDCS study. J Affect Disorders. 2020;265:460–467. doi:10.1016/j.jad.2020.01.11832090773
   PubMed Web of Science ®Google Scholar
• Fregni F, El-Hagrassy MM, Pacheco-Barrios K, et al. Evidence-based guidelines and secondary meta-analysis for the use of transcranial direct current stimulation (tDCS) in neurological and psychiatric disorders. Int j Neuropsychopharmacol. 2020.
   Web of Science ®Google Scholar
• Meron D, Hedger N, Garner M, Baldwin DS. Transcranial direct current stimulation (tDCS) in the treatment of depression: systematic review and meta-analysis of efficacy and tolerability. Neurosci Biobehav Rev. 2015;57:46–62. doi:10.1016/j.neubiorev.2015.07.01226232699
   PubMed Web of Science ®Google Scholar
• Mutz J, Edgcumbe DR, Brunonimd AR, Fumd CHYF. Efficacy and acceptability of non-invasive brain stimulation for the treatment of adult unipolar and bipolar depression: a systematic review and meta-analysis of randomised sham-controlled trials. Neurosci Biobehav Rev. 2018;92:291–303. doi:10.1016/j.neubiorev.2018.05.01529763711
   PubMed Web of Science ®Google Scholar
• Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ (Clinical Research Ed). 2019;364:l1079. doi:10.1136/bmj.l1079
   PubMed Web of Science ®Google Scholar
• Leuchter AF, Cook IA, Hunter AM, Cai C, Horvath S. Resting-state quantitative electroencephalography reveals increased neurophysiologic connectivity in depression. PLoS One. 2012;7(2):e32508. doi:10.1371/journal.pone.003250822384265
   PubMed Web of Science ®Google Scholar
• de Aguiar Neto FS, Rosa JLG. Depression biomarkers using non-invasive EEG: a review. Neurosci Biobehav Rev. 2019;105:83–93. doi:10.1016/j.neubiorev.2019.07.02131400570
   PubMed Web of Science ®Google Scholar
• Alexander ML, Alagapan S, Lugo CE, et al. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019;9(1):106. doi:10.1038/s41398-019-0439-030837453
   PubMed Web of Science ®Google Scholar
• Antal A, Alekseichuk I, Bikson M, et al. Low intensity transcranial electric stimulation: safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017;128(9):1774–1809.28709880
   PubMed Web of Science ®Google Scholar
• Moffa AH, Brunoni AR, Fregni F, et al. Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: analysis of individual patient data. J Affect Disord. 2017;221:1–5. doi:10.1016/j.jad.2017.06.02128623732
   PubMed Web of Science ®Google Scholar
• Palm U, Schiller C, Fintescu Z, et al. Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study. Brain Stimul. 2012;5(3):242–251. doi:10.1016/j.brs.2011.08.00521962978
   PubMed Web of Science ®Google Scholar
• Li MS, Chen YY, Hung GC. Rapid onset of hypomania associated with transcranial direct current stimulation in a patient with bipolar depression. Brain Stimul. 2016;9(6):955–956. doi:10.1016/j.brs.2016.08.00827615791
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Valiengo L, Baccaro A, et al. The sertraline vs electrical current therapy for treating depression clinical study results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013;70(4):383–391. doi:10.1001/2013.jamapsychiatry.3223389323
   PubMed Web of Science ®Google Scholar
• Valiengo L, Bensenor IM, Goulart AC, et al. The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. Depress Anxiety. 2013;30(7):646–653. doi:10.1002/da.2207923625554
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Valiengo L, Zanao T, de Oliveira JF, Bensenor IM, Fregni F. Manic psychosis after sertraline and transcranial direct-current stimulation. J Neuropsychiatry Clin Neurosci. 2011;23(3):E4–5. doi:10.1176/jnp.23.3.jnpe4
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Moffa AH, Sampaio-Júnior B, Gálvez V, Loo CK. Treatment-emergent mania/hypomania during antidepressant treatment with transcranial direct current stimulation (tDCS): a systematic review and meta-analysis. Brain Stimul. 2017;10(2):260–262. doi:10.1016/j.brs.2016.11.00527916405
   PubMed Web of Science ®Google Scholar
• McLaren ME, Nissim NR, Woods AJ. The effects of medication use in transcranial direct current stimulation: a brief review. Brain Stimul. 2018;11(1):52–58. doi:10.1016/j.brs.2017.10.00629066167
   PubMed Web of Science ®Google Scholar
• Cipriani A, Furukawa TA, Salanti G, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391(10128):1357–1366. doi:10.1016/S0140-6736(17)32802-729477251
   PubMed Web of Science ®Google Scholar
• Zhong C, Zeng H, Zhang X, Li Y. Application of antidepressant drugs in a hospital from 2014 to 2016. China Pharm. 2018;27:75–78.
   Google Scholar
• Wang L, Wu F. Analysis of the utilization of antidepressant drugs in 11 hospitals from Zhejiang province during 2013–2017. China Pharmacy. 2019;30(05):134–137.
   Google Scholar
• Qin J, Zhang Y, Liang Y. Antidepressants use in Chinese PLA General Hospital from 2012 to 2016. Acad J Chin Pla Med School. 2017;038(8):P.802–806.
   Google Scholar
• Pan H, Liu H, Xu J, Wang J. Application of antidepressive drugs used in 31 hospitals of Nanjing area during 2013 to 2015. China Pharmacy. 2016;35.
   Google Scholar
• Guo C, Zhang Y, Qiao Z, Du W. Analysis of antidepressant drugs used in our hospital from 2014 to 2016. China Pharm. 2017;12.
   Google Scholar
• McIntyre RS, Filteau M-J, Martin L, et al. Treatment-resistant depression: definitions, review of the evidence, and algorithmic approach. J Affect Disorders. 2014;156:1–7. doi:10.1016/j.jad.2013.10.04324314926
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Moffa AH, Sampaio-Junior B, et al. Trial of electrical direct-current therapy versus escitalopram for depression. N Engl J Med. 2017;376(26):2523–2533. doi:10.1056/NEJMoa161299928657871
   PubMed Web of Science ®Google Scholar
• Ww F, Bm G, S K. Review of transcranial direct current stimulation in poststroke recovery. Top Stroke Rehabil. 2013;20:68–77. doi:10.1310/tsr2001-6823340073
   PubMed Web of Science ®Google Scholar
• Milev RV, Giacobbe P, Kennedy SH, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 clinical guidelines for the management of adults with major depressive disorder: section 4. Neurostimulation Treatments. Can J Psychiatry. 2016;61(9):561–575. doi:10.1177/070674371666003327486154
   PubMed Web of Science ®Google Scholar
• Loo CK, Husain MM, McDonald WM, et al. International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018;11(1):125–133. doi:10.1016/j.brs.2017.10.01129111077
   PubMed Web of Science ®Google Scholar
• Boonstra TW, Nikolin S, Meisener A-C, Martin DM, Loo CK. Change in mean frequency of resting-state electroencephalography after transcranial direct current stimulation. Front Hum Neurosci. 2016;10:270. doi:10.3389/fnhum.2016.0027027375462
   PubMed Web of Science ®Google Scholar
• Bajbouj M, Aust S, Spies J, et al. PsychotherapyPlus: augmentation of cognitive behavioral therapy (CBT) with prefrontal transcranial direct current stimulation (tDCS) in major depressive disorder-study design and methodology of a multicenter double-blind randomized placebo-controlled trial. Eur Arch Psychiatry Clin Neurosci. 2018;268(8):797–808. doi:10.1007/s00406-017-0859-x29214483
   PubMed Web of Science ®Google Scholar
• de Beurs E, Carlier IVE, van Hemert AM. Approaches to denote treatment outcome: clinical significance and clinical global impression compared. Int J Methods Psychiatr Res. 2019;28(4):e1797. doi:10.1002/mpr.179731597212
   PubMed Web of Science ®Google Scholar
• Bernstein IH, Rush AJ, Stegman D, Macleod L, Witte B, Trivedi MHA. Comparison of the QIDS-C16, QIDS-SR16, and the MADRS in an Adult Outpatient Clinical Sample. CNS Spectr. 2010;15(7):458–468. doi:10.1017/S109285290000038920625366
   PubMed Web of Science ®Google Scholar
• Berg EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948;39:15–22. doi:10.1080/00221309.1948.991815918889466
   PubMed Web of Science ®Google Scholar
• Wagner S, Doering B, Helmreich I, Lieb K, Tadić A. A meta-analysis of executive dysfunctions in unipolar major depressive disorder without psychotic symptoms and their changes during antidepressant treatment. Acta Psychiatr Scand. 2012;125(4):281–292. doi:10.1111/j.1600-0447.2011.01762.x22007857
   PubMed Web of Science ®Google Scholar
• Lai CH. Gray matter volume in major depressive disorder: a meta-analysis of voxel-based morphometry studies. Psychiatry Res. 2013;211(1):37–46. doi:10.1016/j.pscychresns.2012.06.00623146253
   PubMed Web of Science ®Google Scholar
• Bora E, Fornito A, Pantelis C, Yucel M. Gray matter abnormalities in Major Depressive Disorder: a meta-analysis of voxel based morphometry studies. J Affect Disord. 2012;138(1–2):9–18. doi:10.1016/j.jad.2011.03.04921511342
   PubMed Web of Science ®Google Scholar
• Fonseka TM. Neuroimaging biomarkers as predictors of treatment outcome in Major Depressive Disorder. J Affect Disorders. 2018;233(1):21–35. doi:10.1016/j.jad.2017.10.04929150145
   PubMed Web of Science ®Google Scholar
• Wise T, Radua J, Via E, et al. Common and distinct patterns of grey-matter volume alteration in major depression and bipolar disorder: evidence from voxel-based meta-analysis. Mol Psychiatry. 2017;22(10):1455–1463. doi:10.1038/mp.2016.7227217146
   PubMed Web of Science ®Google Scholar
• Costafreda SG, Chu C, Ashburner J, Fu CH. Prognostic and diagnostic potential of the structural neuroanatomy of depression. PLoS One. 2009;4(7):e6353. doi:10.1371/journal.pone.000635319633718
   PubMed Web of Science ®Google Scholar
• Bulubas L, Padberg F, Bueno PV, et al. Antidepressant effects of tDCS are associated with prefrontal gray matter volumes at baseline: evidence from the ELECT-TDCS trial. Brain Stimul. 2019;12(5):1197–1204. doi:10.1016/j.brs.2019.05.00631105027
   PubMed Web of Science ®Google Scholar
• Fu CH, Costafreda SG, Sankar A, et al. Multimodal functional and structural neuroimaging investigation of major depressive disorder following treatment with duloxetine. BMC Psychiatry. 2015;15:82. doi:10.1186/s12888-015-0457-225880400
   PubMed Web of Science ®Google Scholar
• Smith R, Chen K, Baxter L, Fort C, Lane RD. Antidepressant effects of sertraline associated with volume increases in dorsolateral prefrontal cortex. J Affect Disord. 2013;146(3):414–419. doi:10.1016/j.jad.2012.07.02923017544
   PubMed Web of Science ®Google Scholar
• Brunoni AR, Valiengo L, Baccaro A, et al. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial–SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011;32(1):90–98. doi:10.1016/j.cct.2010.09.00720854930
   PubMed Web of Science ®Google Scholar
• Fortney L. Foundations of clinical research: applications to practice. Connecticut Appleton Lange. 2013;53.
   Google Scholar
• Bennabi D, Nicolier M, Monnin J, et al. Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram. Clin Neurophysiol. 2015;126(6):1185–1189. doi:10.1016/j.clinph.2014.09.02625454337
   PubMed Web of Science ®Google Scholar
• Palm U, Hasan A, Strube W, Padberg F. tDCS for the treatment of depression: a comprehensive review. Eur Arch Psychiatry Clin Neurosci. 2016;266(8):681–694. doi:10.1007/s00406-016-0674-926842422
   PubMed Web of Science ®Google Scholar
• Dreher A, Hahn E, Diefenbacher A, et al. Cultural differences in symptom representation for depression and somatization measured by the PHQ between Vietnamese and German psychiatric outpatients. J Psychosom Res. 2017;102:71–77. doi:10.1016/j.jpsychores.2017.09.01028992900
   PubMed Web of Science ®Google Scholar
• Jeon HJ, Walker RS, Inamori A, et al. Differences in depressive symptoms between Korean and American outpatients with major depressive disorder. Int Clin Psychopharmacol. 2014;29(3):150–156. doi:10.1097/YIC.000000000000001924323201
   PubMed Web of Science ®Google Scholar
• Ryder AG, Chentsova-Dutton YE. Depression in cultural context: “Chinese somatization,” revisited. Psychiatr Clin North Am. 2012;35(1):15–36. doi:10.1016/j.psc.2011.11.00622370488
   PubMed Web of Science ®Google Scholar
• Tallon D, Mulligan J, Wiles N, et al. Involving patients with depression in research: survey of patients’ attitudes to participation. Br J Gen Pract. 2011;61(585):134–141. doi:10.3399/bjgp11X56703621439170
   PubMed Web of Science ®Google Scholar
• Fonteneau C, Mondino M, Arns M, et al. Sham tDCS: a hidden source of variability? Reflections for further blinded, controlled trials. Brain Stimul. 2019;12:668–673. doi:10.1016/j.brs.2018.12.97730639235
   PubMed Web of Science ®Google Scholar