Neuromod Publishes Results of Second Large Scale Clinical Trial for Tinnitus in Top-Tier Scientific Journal, Shows Greater Improvement of Symptoms – PR Newswire UK
The full paper is available here: TENT-A2 results[1].
Tinnitus, commonly referred to as “ringing in the ears” is thought to affect between 10 – 15% of the global adult population[2,3]. The TENT-A2 trial, which included 191 participants, is the company’s second large-scale clinical trial and sought to replicate and further enhance the results demonstrated in the company’s TENT-A1 trial, a study that evaluated the safety and efficacy of Lenire®, the company’s non-invasive bimodal ne…….
The full paper is available here: TENT-A2 results[1].
Tinnitus, commonly referred to as “ringing in the ears” is thought to affect between 10 – 15% of the global adult population[2,3]. The TENT-A2 trial, which included 191 participants, is the company’s second large-scale clinical trial and sought to replicate and further enhance the results demonstrated in the company’s TENT-A1 trial, a study that evaluated the safety and efficacy of Lenire®, the company’s non-invasive bimodal neuromodulation device in 326 participants.
The publication of the TENT-A2 results in Nature – Scientific Reports follows on from the publication of the TENT-A1 results as the cover story in Science – Translational Medicine in 2020 (the full TENT-A1 results paper is available here: TENT-A1 results)[4]. This second major publication continues Neuromod’s strategy to establish the clinical credibility of bimodal neuromodulation through publishing large-scale clinical trials in top-tier peer-reviewed journals.
The TENT-A2 study investigated if changing treatment stimuli after six weeks of treatment would result in greater improvement in tinnitus symptoms than observed in the TENT-A1 study, during which participants were treated with the same stimuli for the entire 12-week treatment period.
In the TENT-A1 study, treatment compliant participants demonstrated a mean improvement that was more than twice the published clinically important improvement. In the TENT-A2 study, 95% of treatment compliant participants achieved a greater average improvement in symptoms compared to TENT-A1[1,4,5] and almost three times the published clinically important improvement. 91% of treatment compliant participants achieved an improvement that sustained 12 months after treatment concluded[1,5].
TENT-A2 is the second large-scale clinical trial validating the safety, with high patient satisfaction and tolerability, of bimodal neuromodulation as a treatment for tinnitus while also demonstrating greater efficacy in reducing tinnitus symptoms through optimised treatment regimens compared to the first large-scale trial.
Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire and available commercially throughout Europe, was developed by Neuromod. It consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli.
The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.
Similarly to TENT-A1, participants in the TENT-A2 trial were instructed to use Lenire for 60 minutes each day for 12 weeks. …….
