Here is a sneak preview “summary” of the most recent Lenire (Neuromod) device clinical trial results.
It is an abstract.
It is from the Association for Research in Otolaryngology’s 43rd Annual MidWinter Meeting’s Abstract Book: Abstracts 488 Volume 43, 2020 (PS 767).
It is exciting.
But remember to keep a few important points in mind while reading:
- This information has NOT been peer-reviewed (yet)
- The studies this information is based on did NOT involve any placebo-group(s)
Here it is:
Safety and Efficacy of Combined Sound and Trigeminal Nerve (Tongue) Stimulation to Treat Tinnitus: Effects of Different Stimulation Settings over Time
Hubert H. Lim, Caroline Hamilton, Stephen Hughes, Emma Meade, Martin Schecklmann, Thavakumar Subramaniam, Sven Vanneste, Deborah Hall, Berthold Langguth, Brendan Conlon
University of Minnesota, Minneapolis, USA, St. James’s Hospital/Trinity College Dublin, Neuromod Devices Limited, University of Regensburg, The University of Texas at Dallas, University of Nottingham
Tinnitus affects 10-15% of the population. Unfortunately, there are limited treatment options. Recent animal and pilot human research has demonstrated the ability to drive extensive auditory plasticity and potentially treat tinnitus by pairing sound with trigeminal or somatosensory nerve activation, such as with tongue stimulation. A non-invasive device (Lenire) using auditory and tongue (bimodal) stimulation was evaluated in two large randomized and blinded clinical trials in over 500 participants with tinnitus in Ireland and Germany. The first study (TENT-A1) investigated three stimulation settings (PS1, PS2, PS3) presented for 12 weeks (60 minutes recommended per day) and evaluated during treatment and up to 12 months post-treatment (326 enrolled participants). Primary outcome measures included the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI). The second study (TENT-A2) investigated different stimulation settings over time across four treatment arms (191 enrolled participants). The first treatment arm consisted of the most effective stimulation setting from TENT-A1 during the first 6-weeks (PS1) followed by a new bimodal stimulation setting during the second 6-weeks (PS4). The second and third arms consisted of different bimodal settings than the first arm, while the fourth arm consisted of an acoustic only condition during the first 6-weeks followed by a bimodal condition during the second 6-weeks. All three stimulation settings in TENT-A1 resulted in statistically significant improvements in tinnitus for THI (p< 0.0001) and TFI (p< 0.0001) that were also clinically significant ( >7 THI points, >13 TFI points). Post-treatment, PS1 resulted in persistent improvements lasting 12 months after treatment ceased (p< 0.0001). The treatment was safe and well-tolerated with a high compliance rate (84%; >36 hours of usage). The largest therapeutic effects occurred within the first 6-weeks. In TENT-A2, similar results were observed for PS1 during the first 6-weeks as in TENT-A1. Changing the stimulation setting from PS1 to PS4 led to a greater improvement (p< 0.001) than observed in TENT-A1 that also persisted for 12 months post-treatment, as well as reaching a higher compliance rate of 91%. Post-hoc analyses showed that different bimodal stimulation settings over time could be as effective as the PS1-to-PS4 condition and that specific bimodal stimuli consistently outperformed the acoustic only condition for both THI and TFI. Overall, these findings demonstrate that the Lenire treatment provides safe, fast-acting (within 6 weeks) and reproducible therapeutic effects that can last at least 12 months. Furthermore, adjusting the stimulation settings time can drive greater therapeutic effects.
The complete results and supporting data will probably only be available (published in a peer-reviewed journal) in Q1 2021 or Q2 2021.
This information is presented without further comment.
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