Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study
| Autor: | Shona D'Arcy, Hubert H. Lim, Ciara O Connor, Brendan Conlon, Sook Ling Leong, Sven Vanneste, Berthold Langguth, Caroline Hamilton, Thavakumar Subramaniam, Emma Meade, Stephen Hughes, Martin Schecklmann, Deborah A. Hall |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Research design
Adult medicine.medical_specialty Population Audiology law.invention Cohort Studies 03 medical and health sciences Tinnitus 0302 clinical medicine Randomized controlled trial Tongue law medicine otorhinolaryngologic diseases Animals Humans 030223 otorhinolaryngology Adverse effect education education.field_of_study business.industry General Medicine Neuromodulation (medicine) Electric Stimulation Clinical trial Treatment Outcome Research Design medicine.symptom business 030217 neurology & neurosurgery Cohort study |
| ISSN: | 1946-6242 |
| Popis: | Tinnitus is a phantom auditory perception coded in the brain that can be bothersome or debilitating for 10-15% 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 adult subjects 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 post-treatment 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 |
| Databáze: | OpenAIRE |
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