Neuromod Devices has published the results of the company’s TENT-A2 (Treatment evaluation of neuromodulation for tinnitus—stage A2) clinical trial in Scientific Reports via a paper titled “Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial”.
The TENT-A2 trial, which included 191 participants, is Neuromod’s second large-scale clinical trial, and sought to replicate and further enhance the results demonstrated in the TENT-A1 trial—a study that evaluated the safety and efficacy of the company’s non-invasive bimodal neuromodulation device, Lenire, in 326 participants.
The more recent study investigated if changing treatment stimuli after six weeks of treatment would result in greater improvement in tinnitus symptoms than that 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 and almost three times the published clinically important improvement. And, according to a Neuromod press release, 91% of treatment-compliant participants achieved an improvement that sustained 12 months after treatment concluded.
TENT-A2 is the second large-scale clinical trial validating the safety of bimodal neuromodulation as a treatment for tinnitus, with high patient satisfaction and tolerability, while also demonstrating greater efficacy in reducing tinnitus symptoms through optimised treatment regimens compared to the first large-scale trial, the release adds.
Similarly to TENT-A1, participants in the TENT-A2 trial were instructed to use Lenire for 60 minutes each day for 12 weeks. However, after an initial six weeks of treatment, the timing and delivery of the audio and tongue stimuli delivered by the device were changed for participants of the TENT-A2 trial for their remaining six weeks of treatment. In TENT-A1, the stimulation setting remained the same for the full 12 weeks of treatment. This change in treatment regimen resulted in a greater average reduction in tinnitus symptom severity being achieved by treatment-compliant participants.
The study was conducted at the Wellcome Trust-HRB Clinical Research Facility at St James’s Hospital, Dublin, Ireland with no treatment-related serious adverse events reported and a high treatment compliance. Out of 191 enrolled participants, 83.8% used the device at or above the minimum compliance level over the 12-week treatment period.
When treatment was completed, participants returned their devices and were assessed at three follow-up appointments up to 12 months. Some 70.3% of the 172 participants who filled out the exit survey said they had benefitted from using the treatment and 87.8% said they would recommend other people with tinnitus to try the treatment.