Tinnitus Treatment Report

www.TinnitusTreatmentReport.com

Neuromod

Study findings demonstrate that Lenire (Neuromod) for tinnitus “provides safe, fast-acting (within 6 weeks) and reproducible therapeutic effects that can last at least 12 months.”

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  • This information has NOT been peer-reviewed (yet)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.

What do you think of this Lenire update? Discuss it in the Tinnitus Talk forums, on Reddit (r/tinnitus and r/tinnitusresearch), in Facebook groups, and on Twitter. Ask lots of questions. Or send an email to michael@urgentresearch.com with your opinion and commentary.

To get more exclusive tinnitus treatment-related updates delivered to your inbox, subscribe to the Tinnitus Treatment Report email updates list. It is a free once-weekly link roundup and newsletter that will be sending out its first issue very soon.

Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters

hhttps://www.researchprotocols.org/2019/9/e13176/

ttps://www.ncbi.nlm.nih.gov/pubmed/31573942?dopt=Abstract

Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters.

JMIR Res Protoc

Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters.

JMIR Res Protoc. 2019 Sep 27;8(9):e13176

Authors: Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH

Abstract

BACKGROUND: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus.

OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.

METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)-marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported.

RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James’s Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.

CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13176.

PMID: 31573942 [PubMed]

PubMed:31573942

Neuromod updates anticipated study completion date of device clinical trial

A mysterious update related to Neuromod’s neuromodulation device…

Last Tuesday, Neuromod Devices Ltd. quietly updated the official study records of its two active neuromodulation device clinical trials.

The update changed the anticipated Study Completion date from February 2019 to July 2019 – a five month delay.

A similar update occurred back in late December, too. That update also delayed the anticipated Study Completion date for the neuromod device study.

July 2019 or…

Neuromod device study completion date delay

Considering July 2019 is only two months away, this does not appear to be cause for concern.

However, one can’t help but wonder what this means. Without an explanation or comment from Neuromod, this mysterious “delay” could fuel some wild speculation.

Developing…

Are we there yet are we there yet how about now, Neuromod?

This post will be updated if and/or when Neuromod provides an update or clarifies the situation.

UPDATE

Dr. Ross O’Neill, CEO of Neuromod commented: “This is a very exciting time for Neuromod as we move towards commercialisation, supported by encouraging data from our recent clinical trials. I am delighted that industry leaders of the calibre of Deb, Suzanne and Cathal have agreed to join our team. Neuromod is investing in growing our organisation; we have been working tirelessly to ensure that all systems are in place to bring our much-anticipated breakthrough treatment to the large population of people living with tinnitus globally.”

SOURCE: https://www.businesswire.com/news/home/20190508005314/en/Neuromod-Broadens-Senior-Leadership-Team-Preparation-Global/

References:
https://clinicaltrials.gov/ct2/show/NCT03530306
https://clinicaltrials.gov/ct2/show/NCT02669069

Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2 (TENT-A2) [Neuromod]

https://clinicaltrials.gov/ct2/show/NCT03530306?type=Intr&cond=Tinnitus&phase=012345&lupd_s=12%2F06%2F2018&lupd_d=14

Condition :   Tinnitus

Interventions :   Device: PS1-PS4;   Device: PS6-PS10;   Device: PS7-PS4;   Device: PS9-PS6

Sponsor :   Neuromod Devices Ltd.

Active, not recruiting

Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2

Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2 (TENT-A2)

NCT03530306

Mon, 21 May 2018 12:00:00 EDT

>>> updated study, phase n/a and protocol posted

https://clinicaltrials.gov/ProvidedDocs/06/NCT03530306/Prot_SAP_000.pdf

NEUROMOD VIDEO: “New Treatment for Tinnitus Evaluated in over 500 Patients” [Dr. Hubert Lim presentation]

Full video presentation from Dr. Hubert Lim, Chief Scientific Officer of Neuromod Devices, at last month’s American Auditory Society Scientific and Technology Meeting.

The 29-minute video is jam-packed with new details about the much-anticipated Neuromod device (also known as Lenire).

Video: RP308 – Reproducible and Long-Term Efficacy of a New Treatment for Tinnitus Evaluated in over 500 Patients”

UPDATE: May 18, 2019 – The link to the video is broken. It looks like the source file was recently removed or deleted.

Another upcoming Neuromod Device podium abstract “from the future” (March 29, 2019) – with some interesting implications…

This podium presentation preview was uncovered on the American Academy of Audiology’s AAA 2019 Conference Planner website.

It appears to be a public post (i.e. not a “leak” or “accidental release”), but judging by its view count (33 views as of 02/22/2019 2:40 pm EST), it has not been heavily publicized or received much attention.

TITLE: RP308 – Reproducible and Long-Term Efficacy of a New Treatment for Tinnitus Evaluated in over 500 Patients

SOURCE: https://www.eventscribe.com/2019/AAA-2019/fsPopup.asp?Mode=presInfo&PresentationID=491462

So what?

At a glance, this podium abstract doesn’t look much different than the recently-uncovered Neuromod Device study result abstract dated March 2, 2019.

However, there is one small (but significant) detail that is worth pointing out…

Something that offers us insights into the current status of the Neuromod Device and whether or not the company is actively preparing for its public release and distribution to doctors and clinics.

Small abstract, big clues… (take another look)

Top right corner:

CE: 0.05

The CE stands for Continuing Education. The 0.05 is the number of CE credits this presentation offers attendees.

Last paragraph:

Learning Objectives

Think about it.

Hubert Lim, PHD – the Chief Scientific Officer of Neuromod – is traveling across the country… but NOT simply to present and hype up the exciting study results…

Rather, he is on a mission to TEACH audiologists how to “implement this treatment” in their clinics for their tinnitus patients.

Which might have you wondering…

Would he be doing that if Neuromod’s study results were clinically insignificant?

Would he be doing that if the device was not very close to a commercial release?

Would audiologists get CE credits for a presentation about a device that did not work?

Time will tell.

 

NEUROMOD RESULTS: “Reproducible and Long-Term Efficacy of a New Treatment for Tinnitus”

Neuromod Device study results accidentally posted online or just very hard to find?

This information was discovered within a .pdf document hosted on the American Auditory Society website. The 19-page document is a collection of podium abstracts for the upcoming American Auditory Society Scientific and Technology Meeting (February 28 – March 2, 2019). And one of these abstracts is for the long-awaited Neuromod Device study results.

Interestingly, the web address where this information was found is “public” and indexed by Google (see screenshot). However, for some reason it is post-dated March 2, 2019. Was this abstract supposed to be public so soon?

Neuromod Device study results abstract… from the future?

Neuromod Device study results (podium abstract) from upcoming AAS meeting

Reproducible and Long-Term Efficacy of a New Treatment for Tinnitus

Tinnitus affects ~10-15% of the population. Unfortunately, there are limited treatment options. A new non-invasive neuromodulation device using auditory (sound) and trigeminal nerve (tongue) stimulation has been evaluated in more than 500 tinnitus patients across two randomized and blinded clinical trials. The first study explored the effects of three MBT stimulation settings (PS1, PS2, PS3) that were presented for 12 weeks (~30-60 minutes per day) and evaluated during treatment and up to 12 months posttreatment (326 enrolled patients). Pre-specified primary outcome measures included the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI). All three MBT settings resulted in statistically and clinically significant improvements in tinnitus during treatment. Post-treatment, PS1 resulted in long-term improvements lasting 12 months that clinically outperformed the other stimulation settings. The treatment was safe and well-tolerated with a high compliance rate (84%). Encouragingly, the greatest therapeutic effects were observed within the first 6 weeks of treatment, which was repeatable for PS1 in an ongoing second clinical trial in 191 patients. These two clinical trials represent one of the largest clinical trial datasets for tinnitus treatments, demonstrating safe, fast-acting (within 6 weeks) and reproducible therapeutic effects that can last at least 12 months with appropriate stimulation settings.

SOURCE:
https://aas.memberclicks.net/assets/19_Podiums.pdf

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) [Neuromod]

https://clinicaltrials.gov/ct2/show/NCT02669069?type=Intr&cond=Tinnitus&phase=012345&lupd_s=12%2F19%2F2018&lupd_d=14

Condition :   Tinnitus

Interventions :   Device: PS1;   Device: PS2;   Device: PS3

Sponsors :   Neuromod Devices Ltd.;   University Hospital Regensburg

Active, not recruiting

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

NCT02669069

Fri, 29 Jan 2016 12:00:00 EST

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