Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

Brendan Conlon, Berthold Langguth, Caroline Hamilton, Stephen Hughes, Emma Meade, Ciara O'Connor, Martin Schecklmann, Deborah A Hall, Sven Vanneste, Sook Ling Leong, Thavakumar Subramaniam, Shona D'Arcy, Hubert H Lim

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Tinnitus is a phantom auditory perception coded in the brain that can be bothersome or debilitating, affecting 10 to 15% of the population. Currently, there is no clinically recommended drug or device treatment for this major health condition. Animal research has revealed that sound paired with electrical somatosensory stimulation can drive extensive plasticity within the brain for tinnitus treatment. To investigate this bimodal neuromodulation approach in humans, we evaluated a noninvasive device that delivers sound to the ears and electrical stimulation to the tongue in a randomized, double-blinded, exploratory study that enrolled 326 adults with chronic subjective tinnitus. Participants were randomized into three parallel arms with different stimulation settings. Clinical outcomes were evaluated over a 12-week treatment period and a 12-month posttreatment phase. For the primary endpoints, participants achieved a statistically significant reduction in tinnitus symptom severity at the end of treatment based on two commonly used outcome measures, Tinnitus Handicap Inventory (Cohen's d effect size: -0.87 to -0.92 across arms; P < 0.001) and Tinnitus Functional Index (-0.77 to -0.87; P < 0.001). Therapeutic improvements continued for 12 months after treatment for specific bimodal stimulation settings, which had not previously been demonstrated in a large cohort for a tinnitus intervention. The treatment also achieved high compliance and satisfaction rates with no treatment-related serious adverse events. These positive therapeutic and long-term results motivate further clinical trials toward establishing bimodal neuromodulation as a clinically recommended device treatment for tinnitus.

Original languageEnglish (US)
Article numbereabb2830
JournalScience Translational Medicine
Volume12
Issue number564
DOIs
StatePublished - Oct 7 2020

Bibliographical note

Funding Information:
This work was sponsored by Neuromod Devices (Dublin, Ireland).

Publisher Copyright:
Copyright © 2020 The Authors.

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't
  • Randomized Controlled Trial

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