Conlon, Brendan and Langguth, Berthold and Hamilton, Caroline and Hughes, Stephen and Meade, Emma and Connor, Ciara O. and Schecklmann, Martin and Hall, Deborah A. and Vanneste, Sven and Leong, Sook Ling and Subramaniam, Thavakumar and D'Arcy, Shona and Lim, Hubert H. (2020) Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. SCIENCE TRANSLATIONAL MEDICINE, 12 (564): eabb2830. ISSN 1946-6234, 1946-6242
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | TRIGEMINAL NERVE-STIMULATION; DORSAL COLUMN NUCLEI; COCHLEAR NUCLEUS; VAGUS NERVE; HEARING-LOSS; PROJECTIONS; PLASTICITY; DISORDERS; INVENTORY; STATE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie Medicine > Zentren des Universitätsklinikums Regensburg > Tinnituszentrum |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Mar 2021 07:42 |
| Last Modified: | 09 Mar 2021 07:42 |
| URI: | https://pred.uni-regensburg.de/id/eprint/43593 |
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