Long-term effect of transcranial direct current stimulation in the treatment of chronic tinnitus: A randomized, placebo-controlled trial

Tadeas Mares, Jakub Albrecht, Jozef Buday, Gabriela Podgorna, Thai Hong Le, Eva Magyarova, Katerina Poshor, Jakub Halik, Jan Buna, Vaclav Capek, Lenka Kostylkova, Johana Klasova, Vratislav Fabian, Martin Anders, Tadeas Mares, Jakub Albrecht, Jozef Buday, Gabriela Podgorna, Thai Hong Le, Eva Magyarova, Katerina Poshor, Jakub Halik, Jan Buna, Vaclav Capek, Lenka Kostylkova, Johana Klasova, Vratislav Fabian, Martin Anders

Abstract

Introduction: Tinnitus is an intrusive and chronic illness affecting a significant portion of the population, decreasing affected individuals' quality of life and socioeconomic functioning. Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes. Several studies have proven its effect on tinnitus. We aimed to broaden the knowledge and provide data on the effect and its retention.

Methods: In the randomized, double-blinded, sham-controlled trial, 39 patients (active n = 19, sham n = 20) underwent bifrontal tDCS (anode over right dorsolateral prefrontal cortex (DLPFC), cathode left DLPFC, current of 1.5 mA, 20 min, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and 6 months.

Results: We reached a delayed, significant long-term improvement (p < 0.05) in auditory difficulties associated with tinnitus and noticed it even after 6 months compared to placebo. We also reached a short-term, negative effect in the psychological domain of WHO-Quality of Life-BREF (p < 0.05). Not all subdomains of TFI and ITHQ reached statistical significance during the data analysis, even though specific positive trends were noticed.

Conclusion: We proved partial, positive, long-term effects of tDCS on tinnitus and short-term, negative, transient effect on a specific aspect of the general quality of life. We expanded upon the results of previous trials and provided data concerning the longevity and the precise effect of multiple sessions, bifrontal DLPFC tDCS. Our sample size (n = 39) was limited, which might have contributed to the lesser statistical power of the analyzed items.

Clinical trial registration: [www.ClinicalTrials.gov], identifier [NCT05437185].

Keywords: bifrontal tDCS; dorsolateral prefrontal cortex; neurostimulation; non-invasive; protocol optimization; tDCS; tinnitus; transcranial direct current stimulation (tDCS).

Conflict of interest statement

Author JA was employed by Krajska zdravotni a.s. – Most Hospital, Most, Czechia since January 2022. The remaining 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 © 2022 Mares, Albrecht, Buday, Podgorna, Le, Magyarova, Poshor, Halik, Buna, Capek, Kostylkova, Klasova, Fabian and Anders.

Figures

FIGURE 1
FIGURE 1
PRISMA diagram of the enrollment process and further compliance with follow-ups.
FIGURE 2
FIGURE 2
Illustration of electrode positioning in 10–20 system. Red-anode, Blue-cathode. Note that the electrodes were squares 5 × 5 cm, not rounds as depicted.
FIGURE 3
FIGURE 3
Chart depicting the outcome changes in the Auditory subdomain of Tinnitus Functional Index compared to the T1 baseline and their side-by-side comparison between the arms. The results in T3 and T4 are statistically significant a denote a decrease (improvement) in the Auditory subdomain of the active group. Note – Real = Active Group, Placebo = Sham Group.
FIGURE 4
FIGURE 4
Line chart depicting the mean values of the Auditory subdomain of Tinnitus Functional Index throughout the trial and their side-by-side comparison between the arms. The results in T3 and T4 are statistically significant a denote a decrease (improvement) in the Auditory subdomain of the active group.

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