Effect of Home-based Self-administered Transcranial Direct Stimulation in Patients with Mild to Moderate Major Depressive Disorder: A Single-arm, Multicentral Trial

Jihoon Oh, Sekye Jeon, Tae Hyon Ha, Woojae Myung, Seung-Hwan Lee, Young-Hoon Ko, Do Hoon Kim, Hwa-Young Lee, Jeong-Ho Chae, Jihoon Oh, Sekye Jeon, Tae Hyon Ha, Woojae Myung, Seung-Hwan Lee, Young-Hoon Ko, Do Hoon Kim, Hwa-Young Lee, Jeong-Ho Chae

Abstract

Objective: Although the effects and safety of transcranial direct current stimulation (tDCS) treatment in depressive patients are largely investigated, whether the self-administration of tDCS treatment at patient's home is comparable to clinic-based treatment is still unknown.

Methods: In this single-arm, multi-center clinical trial, 61 patients with mild to moderate major depressive disorder were enrolled. tDCS treatment was delivered at the patient's home once a day, 5 to 7 times a week for 6 weeks, and each session lasted for 30 minutes. The primary outcome was a total Beck-Depression Inventory-II score, and no concurrent antidepressants were used.

Results: The remission rates in both Full-Analysis (FA) (n = 61) and Per-Protocol (PP) (n = 43) groups were statistically significant (FA: 57.4% [0.44-0.70], PP: 62.8% [0.47-0.77]; percent [95% confidence interval]). The degree of depression- related symptoms was also significantly improved in 2, 4, and 6 weeks after the treatment when compared with baseline. There was no significant association between treatment compliance and remission rate in both FA and PP groups.

Conclusion: These results suggest that acute treatment of patient-administered tDCS might be effective in improving the subjective feeling of depressive symptoms in mild to moderate major depressive disorder patients.

Keywords: At-home treatment; Depression; Patient-administered; tDCS.

Conflict of interest statement

CONFLICT OF INTEREST

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
Fig. 1
(A) Study design and protocols. (B) Enrollment and allocation of groups and drop-out cases. tDCS, transcranial direct current stimulation.
Fig. 2
Fig. 2
Total score changes on psychiatric scales during the six-week treatment period. (A) Beck-Depression Inventory-II score (BDI-II), (B) Hamilton Depression Scale (HAM-D), (C) Beck Anxiety Inventory (BAI). Error bar denotes standard deviation in each point. All differences between visit and baseline were statistically significant (***paried ttest, p < 0.001).

References

    1. Paulus W. Transcranial electrical stimulation (tES - tDCS; tRNS, tACS) methods. Neuropsychol Rehabil. 2011;21:602–617. doi: 10.1080/09602011.2011.557292.
    1. Knechtel L, Thienel R, Schall U. Transcranial direct current stimulation: neurophysiology and clinical applications. Neuro-psychiatry. 2013;3:89–96. doi: 10.2217/npy.12.78.
    1. Khaleghi A, Mohammadi MR, Shahi K, Nasrabadi AM. Com-putational neuroscience approach to psychiatry: a review on theory-driven approaches. Clin Psychopharmacol Neurosci. 2022;20:26–36. doi: 10.9758/cpn.2022.20.1.26.
    1. Demirtas-Tatlidede A, Vahabzadeh-Hagh AM, Pascual-Leone A. Can noninvasive brain stimulation enhance cognition in neuropsychiatric disorders? Neuropharmacology. 2013;64:566–578. doi: 10.1016/j.neuropharm.2012.06.020.
    1. Fitzgerald PB, Oxley TJ, Laird AR, Kulkarni J, Egan GF, Daskalakis ZJ. An analysis of functional neuroimaging studies of dorsolateral prefrontal cortical activity in depression. Psychiatry Res. 2006;148:33–45. doi: 10.1016/j.pscychresns.2006.04.006.
    1. Oh J, Jang KI, Jeon S, Chae JH. Effect of self-administered transcranial direct stimulation in patients with major depressive disorder: a randomized, single-blinded clinical trial. Clin Psychopharmacol Neurosci. 2022;20:87–96. doi: 10.9758/cpn.2022.20.1.87.
    1. 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. 2019;364:l1079. doi: 10.1136/bmj.l1079.
    1. Brunoni AR, Moffa AH, Fregni F, Palm U, Padberg F, Blumberger DM, et al. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016;208:522–531. doi: 10.1192/bjp.bp.115.164715.
    1. Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, et al. Trial of electrical direct-current therapy versus escitalopram for depression. N Engl J Med. 2017;376:2523–2533. doi: 10.1056/NEJMoa1612999.
    1. Brunoni AR, Valiengo L, Baccaro A, Zanão TA, de Oliveira JF, Goulart A, et al. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013;70:383–391. doi: 10.1001/2013.jamapsychiatry.32.
    1. Lisanby SH. Noninvasive brain stimulation for depression - the devil is in the dosing. N Engl J Med. 2017;376:2593–2594. doi: 10.1056/NEJMe1702492.
    1. D'Urso G, Dell'Osso B, Rossi R, Brunoni AR, Bortolomasi M, Ferrucci R, et al. Clinical predictors of acute response to transcranial direct current stimulation (tDCS) in major depression. J Affect Disord. 2017;219:25–30. doi: 10.1016/j.jad.2017.05.019.
    1. Palm U, Hasan A, Strube W, Padberg F. tDCS for the treatment of depression: a comprehensive review. Eur Arch Psychiatry Clin Neurosci. 2016;266:681–694. doi: 10.1007/s00406-016-0674-9.
    1. Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019;252:475–483. doi: 10.1016/j.jad.2019.04.041.
    1. Woo YS, Bahk WM, Seo JS, Park YM, Kim W, Jeong JH, et al. The Korean Medication Algorithm Project for Depressive Disorder 2021: comparisons with other treatment guidelines. Clin Psychopharmacol Neurosci. 2022;20:37–50. doi: 10.9758/cpn.2022.20.1.37.
    1. Yu BK, Lee HK, Lee KS. Validation and factor structure of Korean version of the Beck Depression Inventory second edition (BDI-II): in a university student sample. Korean Soc Biol Psychiatry. 2011;18:126–133.
    1. Yi JS, Bae SO, Ahn YM, Park DB, Noh KS, Shin HK, et al. Validity and reliability of the Korean version of the Hamilton Depression Rating Scale(K-HDRS) J Korean Neuropsychiatr Assoc. 2005;44:456–465.
    1. Lee HK, Lee EH, Hwang ST, Hong SH, Kim JH. Psychometric properties of the Beck Anxiety Inventory in the community- dwelling sample of Korean adults. Korean J Clin Psychol. 2016;35:822–830. doi: 10.15842/kjcp.2016.35.4.010.
    1. Riedel M, Möller HJ, Obermeier M, Schennach-Wolff R, Bauer M, Adli M, et al. Response and remission criteria in major depression--a validation of current practice. J Psychiatr Res. 2010;44:1063–1068. doi: 10.1016/j.jpsychires.2010.03.006.
    1. Berlim MT, van den Eynde F, Tovar-Perdomo S, Daskalakis ZJ. Response, remission and drop-out rates following high-frequency repetitive transcranial magnetic stimulation (rTMS) for treating major depression: a systematic review and meta-analysis of randomized, double-blind and sham-controlled trials. Psychol Med. 2014;44:225–239. doi: 10.1017/S0033291713000512.
    1. Oh J, Jang KI, Jeon S, Chae JH. Effect of self-administered transcranial direct stimulation in patients with major depressive disorder: a randomized, single-blinded clinical trial. Clin Psycho-pharmacol Neurosci. 2022;20:87–96. doi: 10.9758/cpn.2022.20.1.87.
    1. Kessler SK, Turkeltaub PE, Benson JG, Hamilton RH. Differences in the experience of active and sham transcranial direct current stimulation. Brain Stimul. 2012;5:155–162. doi: 10.1016/j.brs.2011.02.007.
    1. Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimul. 2016;9:641–661. doi: 10.1016/j.brs.2016.06.004.
    1. Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007;72:208–214. doi: 10.1016/j.brainresbull.2007.01.004.
    1. Stegenga BT, Kamphuis MH, King M, Nazareth I, Geerlings MI. The natural course and outcome of major depressive disorder in primary care: the PREDICT-NL study. Soc Psychiatry Psychiatr Epidemiol. 2012;47:87–95. doi: 10.1007/s00127-010-0317-9.
    1. Tiller JW, Schweitzer I. Benzodiazepines. Depressants or antidepressants? Drugs. 1992;44:165–169. doi: 10.2165/00003495-199244020-00001.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere