Neuromod Initiates Stage 3 (TENT-A3) Clinical Trial of Lenire Device for Tinnitus Treatment

New Lenire study, “TENT-A3”, is part of a series of investigations into the Lenire bimodal neuromodulation device, and will evaluate the safety and efficacy of Lenire to alleviate the symptoms of chronic, subjective tinnitus.

TENT-A3 (or, “Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3”) was submitted to ClinicalTrials.gov on January 26, 2022, and posted publicly, for the first time, earlier today (February 7, 2022).

Link to the record, followed by some quick comments:

https://clinicaltrials.gov/ct2/show/NCT05227365

Preview of Lenire TENT-A3 study record
Exciting, but please note: “Stage 3” is not the same as “Phase 3”, and TENT-A3 is considered “Phase N/A” (a device trial without a phase)

Here are some quick facts about what we know so far:

The study record lists an estimated Start Date of February 1, 2022. As of today (2/7/2022), the study still has not yet begun recruiting participants. However, the current status of “Not Yet Recruiting” will likely change to “Recruiting”, any day now. (At which point we may also see a more formal announcement from Neuromod/Lenire.) Speaking of recruiting… the study record seems to give us some idea of where the study will take place (recruiting sites), which will include at least three of the following four countries: Ireland, Belgium, Netherlands, Germany. (That oddly specific “three out of four countries” tidbit is due to the fact that the study record specifically mentions “three study sites”… while listing collaborators in four countries. That detail will probably get cleared up as soon as the study status is set to Recruiting.)

Brief summary from the study record:

TENT-A3 is a single arm repeated measures prospective investigation evaluating the safety and efficacy of the Lenire device for tinnitus treatment. The Lenire device provides non-invasive bimodal (sound and tongue) stimulation to alleviate the symptoms of chronic, subjective tinnitus. Participants presenting to one of the three study sites with a diagnosis of chronic subjective tinnitus who meet the inclusion criteria are enrolled in the investigation while the study site is active.

Biggest takeaway for this latest Neuromod Devices Ltd’s Lenire trial, from the study record — the purpose:

The objective of TENT-A3 is to determine whether the addition of tongue stimulation to sound-only stimulation provides additional clinically significant improvements in tinnitus symptoms beyond that of the sound-only stimulation component of the bimodal treatment.

Other important dates and study details for TENT-A3:

  • Primary Completion Date: August 31, 2022 (estimated)
  • Study Completion Date: September 30, 2022 (estimated)
  • Enrollment: 112 participants (estimated)

This article is a draft “early access” copy of a developing story…


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