Introducing Tinnitus Quest

Hi,

I'm not sure where to post questions, so I apologize if this is the wrong place.

Regarding funding, could we ask Dr. Djalilian if he believes the project is fully funded through to commercial launch? I understand that he has raised funds for a clinical trial, as mentioned in the Tinnitus Talk Podcast.

If the project is not fully funded and still needs additional resources, why would funds from the Tinnitus Quest not be used for this purpose? It seems like a very promising treatment.

 

Yes, I understand that.

Maybe that's not been made super-clear. Brian Fargo donated $1m for what appeared to me - further research, trials, etc. If we're beyond that phase and now into "getting his device to market," well... I know from my perspective, I'd be pretty excited about that. But just to pick up on your point about failing to see how this applies to Hamid's research: from my perspective, these questions apply to every current researcher involved with extra-cochlear electrical stimulation (not bi-modal stimulation by the way).

If Heidi Olze was on your board, I'd want to know her point of view, too. Why has it taken more than 40 years for researchers to finally realise this type of tech? (And before we forget, Heidi Olze has stated that the tech, or at least her version of it, is at least another ten years off—well, this was a couple of years ago.)

@Nick47 posted a recent study here.

You don't have to read too far into that study because the second line of the first paragraph states: Since the late 1970s, it has been known that electrical stimulation of the cochlea can achieve partial or complete suppression of tinnitus percepts.

Reference No. 9 states: Portmann M, Cazals Y, Negrevergne M, Aran JM. Temporary tinnitus suppression in man through electrical stimulation of the cochlea. Acta Otorrinolaringol. 1979;87(3-6):294-9.

I've not been able to find a full version of the original paper. However, the abstract can be read here.

I find it pretty vexing that since 1979, the treatment (or at least something remarkably similar) that Hamid is proposing has been languishing in the annals of tinnitus literature. But what do I know? At the end of the day, he could be the one new guy who's finally stepped up to the plate and said, enough already; let's get this thing to market.

I think it would be good to know his point of view on the history of all of this. Or, you could say it's not relevant. But that's where we would have to agree to disagree because certainly, in the context of Tinnitus Quest, I personally think it's entirely relevant and fair to ask.

 

I just listened to the podcast where @Hazel interviewed Dirk De Ridder and Sven. While the podcast was somewhat inspiring, it wasn't necessarily due to any new content or insights. The Tinnitus Quest website already covers the basics well. However, the podcast effectively highlighted, in a very diplomatic way, the frustration we've felt with charities taking us on a merry-go-round for the past 50 years.

I fully support the exploration and treatment of tinnitus using a multidisciplinary approach—or, as De Ridder calls it, a "cocktail." However, I have concerns about the specific components that might make up that cocktail. What worries me more is his persistent focus on addressing tinnitus at the level of the whole brain network. He seems to almost entirely overlook the role of the inner ear, peripheral nerves, and brainstem. There's substantial evidence that tinnitus is either a peripheral phenomenon or, at the very least, triggered by changes in the brainstem, particularly the cochlear nucleus (as shown by Shore, Marks, and Barnes) and the inferior colliculus. His approach seems to pay very little attention to the midbrain. I would have liked to hear his thoughts on extracochlear stimulation, especially considering that one trial is currently in progress and another is set to start soon.

A significant hurdle to overcome, which I personally don't think is entirely possible, is the broader sharing of knowledge between researchers and clinicians. The biggest obstacles here are the potential for profit, licensing agreements, and patents. The number of researchers who actively engage with the patient community and share their ideas is limited to a few noble exceptions. Tinnitus Quest needs to leverage its influence in terms of funding conditions. It would be straightforward for major donors to stipulate specific conditions for their donations—one of which could be removing the right to patent or claim ownership. Setting clear expectations for researchers is crucial, as they often have ingrained ways of conducting research. Regular updates during trials and discussing results before publication are almost unheard of, but they should be encouraged.

When it comes to conducting research, we need to minimize the placebo effect as much as possible. Some essential measures include using crossover designs, adopting more stringent outcome measures (such as MML or >20 TFI), selecting the most severe patients (who are less susceptible to placebo effects), and collecting data at multiple time points. Our goal should be to determine if a treatment truly works rather than merely making it appear effective. Lenire is a classic example of the latter approach, but there are many others.

To encourage researchers, we might consider replacing the term "young investigator" with "new investigator." This would allow experienced researchers who are new to the tinnitus field to apply their ideas—think of someone like Professor Peter McNaughton.

 

Attached is the full paper.

 

I agree 100% with this. In my view, there is very likely some existing treatment that is highly effective in many people but has been missed. This is why my idea was to thoroughly survey every treatment (e.g., summarising every study).

 

Will we be able to watch a replay of the Q&A?

 

If we registered for tomorrow’s Q&A, were we supposed to get an email with a link to tune in?

 

The Oxytocin studies showed great promise and then vanished off the face of the earth. I would love to know what in the heck happened to it. Was all of this made up? Because everyone with tinnitus should get a shot at this, even if it helps only some. It just seems fishy to me.

→ Oxytocin compositions for treatment of tinnitus

 

Hi Hazel. Would it be worth asking Dr. Djalilian or Dr. Olze why they don’t just pool resources and work together on this? It seems like they are both using the same concept. Wouldn’t it be more efficient if they combined their financial resources and knowledge base to get to market quicker? I understand the notion of patents and intellectual property and whatnot, but surely patients should come first?

 

Patients don't always come first, and it's naive to think otherwise. A patent protects against others making and selling an identical product for profit, but it doesn't necessarily prioritize patient needs.

Patents have their place, but my concerns about conflicts of interest stem from the substantial donations made by patients.

As we move forward and raise more funds, it would be wise to discuss patents and ownership more thoroughly. Our financial support should cover labor and materials, but that should be the extent of our involvement.

 

Thank you, Ann!

I'm not annoyed. Frustrated perhaps, but not annoyed.

My comments are observations (right or wrong) about how ongoing research functions. This is just me trying to piece together what I've recently learned is actually a rather long history of extra-cochlear electrical stimulation (ECES) for tinnitus.

I'm intensely interested in ECES because of the genuinely promising results (I even wrote and posted to this forum my own layman's speculative thesis detailing a human brain tinnitus generating mechanism that would fit into the kind of positive endpoints Hamid has seen).

I don't think I've accused anyone of being at fault. What I'm trying to do is gauge the outlook of the clinical experts on the board of an organisation (Tinnitus Quest) that I would consider donating money to.

I'm now realising it's difficult to press the points I would like to raise without it sounding personal, so I don't want to continue with that. I certainly harbour no negative feelings towards any researchers involved with Tinnitus Quest. Perhaps by asking Heidi Olze some questions (thank you for that offer), any underlying concerns I have will be answered there.

Questions for Heidi:

• Citation seems to lie at the heart of ongoing academic research. Specifically regarding your involvement with the Charité project and interactive tinnitus implant; the technology appears remarkably similar to work that was carried out in 1979 by Portmann et al. Are you aware of that research?
  
  
• If you are aware of that research, what reasons, in your view, lie at the heart of the (currently) 45-year delay for the discoveries made by Portmann to (yet) translate into an everyday humanly useful tinnitus treatment?
  
  
• Of course, it's not appropriate to talk about individual funding. However, funding obviously lies right at the heart of all research. Are you able to give an insider's view of how clinical funding works with particular reference to tinnitus? Are there caveats to funding? Generally, is there a commercial imperative (implied or otherwise) that research must lead to a humanly useful product, or do you encounter "funding for funding's sake" or perhaps "research for research's sake"?
  
  
• Finally, one of the closing statements in the 2021 Charité tinnitus implant article noted that "It will certainly take another 10 years before such a complex micro-implant is ready for the market." The "10-year question," as I refer to it, is perhaps the most vexing one I encounter in this subject matter. Traditionally, timespans tend to close before research that builds upon itself is over the target. This was my experience working in the UK aerospace sector many years ago. The only rational explanation I have for research that, I'm afraid I have to say, often seems another ten years away to fruition is that the research itself has reset. Another 10 years is a long time to wait for a mode of treatment that had its genesis 45 years ago. Please could you offer some thoughts on the 10-year question as it relates to your own work on tinnitus and the Portmann study?

 

Thank you so much for organizing the Q&A!

I had to dip in and out, but I look forward to watching it properly later.

I feel more optimistic about the future!

 

If there is interest in navigating the complex process of obtaining U.S. government funding through the NIH, I'm willing to explore ways to make this challenging process easier.

While I understand that Tinnitus Quest is already well into its initial work—securing fundraising and establishing procedures for its utilization—I firmly believe that Tinnitus Quest has the potential to evolve into a global NGO. With its connections and expertise, Tinnitus Quest could leverage national funding sources effectively. My experience is primarily with the U.S. government's grant system.

Each U.S. government agency operates under different "rules" or regulations. For example, the Department of Defense follows completely different regulations and procurement processes than the NIH.

The NIH would likely be Tinnitus Quest’s primary interface.

Online Data systems Tinnitus Quest would need to register for:

1. eRA Commons — This system tracks the status of an award/grant by NIH.
   
   
2. SAM.gov — This is essentially a way to register Tinnitus Quest as an entity eligible for grants. Think of it as a company's headquarters registration, along with some federally required information on who you are, what kind of business (non-profit) you are, and what kind of grants you're interested in.
   
   
3. Grants.gov — Where we'd go to find applicable grants to apply for.
   
   
4. Small Business Administration — A resource that would be able to help set the ground rules and explain in layman's terms what Tinnitus Quest would need to do to achieve its goals of obtaining funding. The NIH has its own subset of the SBA here.

From here, it would be about getting in sync with a small team to understand how to target the grant application process and have a team assess whether the potential funding (grant) justifies the coordination and resources required.

 

I just want to say thank you to @Hazel, @Markku, and the Tinnitus Quest team for organizing the first of many highly informative Q&As! Thank you as well to Dr. Djalilian for staying on for 90 minutes and going into such detail on everything.

I look forward to more events like this one.

 

I thought the Q&A was really well organized and had good, interesting information on different types of tinnitus.

 

Is there a thread here on migraine medications following Dr. Djalilian's talk covering this?

 

I’m following the protocol created by Dr. Djalilian’s telehealth clinic, NeuroMedCare.com. They offer a free consultation to provide a basic overview of the protocol and to answer any questions you might have. The use of migraine medications is optional, and I’ve chosen not to take them. I’m not particularly inclined towards medication, and from reading numerous posts, I’ve noticed that while some people find these medications helpful, others find them harmful.

 

The protocol includes the medications.

Your way is like saying I'm following the HIV protocol but only taking 2 out of the 4 medications.

 

I couldn't take part. Will the recording be published later?

 

Ah, I see your point. Let me explain. My therapist mentioned that they treat people with medication, but some choose to opt-out and follow everything else instead. These individuals still achieve the same results, but it takes them longer to get there—hence my use of the phrase "following the protocol."

 

Can you eventually please add the interview with Dr. Djalilian on YouTube, where I can select the subtitles in my native language, Slovak? I do not fully understand English, and I would like to understand everything that Dr. Djalilian said.

 

I've now watched most of the Q&A, and I think it's good. Dr. Djalilian seems very convinced of the migraine therapy. Have any of you had any experience with it?

I'm not sure if I understood it correctly, but he mentioned that bringing the implant to market would cost "100 million." Please correct me if I'm wrong. These are figures that we, as Tinnitus Quest, simply can't raise. Additionally, as far as I know, the therapy will only help 60-70% of patients.

Please share your thoughts on this.

One approach I haven't seen discussed here is from Erlangen, Germany, called Low Noise Therapy. After two successful pilot studies, a third, larger study is currently underway. The researcher mentioned this in a television report, and I believe I found some information about it on the Tinnitus Quest website.

 

I made my first donation to Tinnitus Quest today. I will try and make one every month if I can.

 

Thank you so much for sharing, @Hazel. I found the information to be quite enlightening, especially since I had no prior knowledge of the migraine protocol/program he offers, which is based on his research. I was particularly surprised to learn that he recommends this protocol for those of us dealing with reactivity and/or hyperacusis.

For those who have reactive tinnitus, hyperacusis, or similar conditions and haven't had the chance to watch the presentation yet, it's important to note that he mentioned a specific approach to treatment. When it comes to electrical stimulation, he would first treat a patient with reactive tinnitus and/or hyperacusis using the migraine protocol/program. His belief is that this protocol can help bring those symptoms under control. After that, he would consider using the electrical stimulation device, depending on whether the reactivity and/or hyperacusis were resolved.

I must admit, I'm quite astonished because I had no idea about the NeuroMed program. Unfortunately, since I'm in Pennsylvania, where they are not yet licensed to practice, I don't currently have access to the migraine program. This is quite disappointing for me.

 

Hi @Hazel:

Regarding funding for new research, could funding be established for projects that have just begun? Will this funding be limited to private companies, or could public institutions also benefit from these donations? Additionally, could researchers working on a molecule (drug) receive support from these funds?

Finally, do you plan to include other researchers on your Scientific Advisory Board in the future? Could volunteers suggest or invite other researchers to join?

 

It doesn’t matter where you are based. They treat and guide you through telehealth (over the internet).