Hough Ear Institute's Hair Cell Regeneration Project

Discussion in 'Research News' started by all to gain, Oct 2, 2019.

    1. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      It's hard to say, hence the reason we want to do the proof-of-concept study. In humans, the damage generally starts 24 hours after the trauma and goes on for about a week. The pill has already been demonstrated to prevent damage if given within 24 hours of trauma AND has show recovery from damage when given much later, weeks later.

      These are all great questions. They help to illuminate the complexity of drug development and all its challenges.
       
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    2. Justin De Moss
      Caffeine

      Justin De Moss Member Benefactor

      Location:
      Oklahoma City, OK
      Tinnitus Since:
      1983
      Cause of Tinnitus:
      My sister, and a firecracker
      I'm sorry you feel that way.

      First, we do have a model that has been tested multiple times with great results. That is what got us excited about the possibility of the drug treating tinnitus. It was originally developed to prevent hearing loss and or help restore hearing. The studies are limiting though. They didn't check for efficacy for long-term tinnitus and they need to be larger in scope and validated by outside researchers.

      As far as Oblato is concerned, I think you assume too much in your analysis of them. We know of the investment with the brain cancer drug. That partner is who introduced us to them and they are very pleased thus far with Oblato. We all need to be careful about relying too much on our own understanding, especially when we are not "in the field". It is one thing to ask the question - perfectly reasonable. It another thing to state as fact something we do not know to be true.

      I get your frustration. But this is really good news. The fact that Oblato is considering paying for half of this study says a lot!

      Lastly, no one ever lied to you. I'm very good at raising money and I'm going to do just that because of people like you. Your suffering, frustration, all of what you and so many others are going through - that is why I do what I do.
       
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    3. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      Look up pramipexole. Several people with presbycusis have had success after using it, it’s a D2 blocker.
      So if you show efficacy for hearing loss, it would be covered by insurance for hearing loss-related claims only though, correct?

      What I’m saying is FX-322 has the experimental arm that would cost you guys $735k for testing specifically for tinnitus—this would suggest that a separate arm is required to have insurance approval for only tinnitus-related claims, right?
       
    4. James1977
      No Mood

      James1977 Member

      Tinnitus Since:
      01/19/2015
      Cause of Tinnitus:
      IMAX Movie
      <rant>Its beyond frustrating that filthy rich tech-billionaires are spending their fortunes racing for Space rather than investing in bio-tech firms that could directly improve the quality of lives of millions.</rant>

      I hope you receive all the needed funds to get this into the hands of people to help soon. It would be devastating lack of funding could have a cure sitting on a shelf.
       
    5. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      This injection tech seems most similar to Regain, and somewhat similar to FX-322 except the latter actually duplicates the support cell in addition to creating an active hair cell. Both of these drugs are in phase 2 and, with FX-322 being fast tracked, will reach the market much quicker than even the pill will.
       
    6. Artemis2K
      Kick ass

      Artemis2K Member Benefactor

      Location:
      South Carolina
      Tinnitus Since:
      2012
      Cause of Tinnitus:
      I had tinnitus for as long as I can remember. Got bad later.
      Sorry, I meant to ask whether or not it can stop/reduce progression.
       
    7. Buzzy1

      Buzzy1 Member

      Tinnitus Since:
      01/1983
      Cause of Tinnitus:
      Ear infection
      Hi @Justin De Moss

      My t started with an ear infection, but it is getting worse now due to hearing loss.

      Is there any information you can give me about the injection? I thought the pill was for age related hearing loss as well. It’s all very confusing, is there a link I can go to for more information?

      Thank you
       
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    8. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      @Hazel and @Markku,

      Tinnitus Talk provides better content than the American Tinnitus Association and British Tinnitus Association combined!

      Wonderful work and highly appreciated.

      Thanks to @Justin De Moss and Dr Kopke (HEI) for agreeing with the interview. Hope to see good results in the future!
       
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    9. Lucifer

      Lucifer Member Podcast Patron Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear Infection
      @Justin De Moss

      When you said they will fund half the cost is that to include tinnitus as an indication?

      Also is the $750k what you need to raise, or do you need to raise $375k?
       
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    10. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      It’s $735k. I don’t think Oblato is funding half of that.
       
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    11. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      You believe the pill can restore damaged nerve endings and synapses in a cochlea in humans which basically means it could treat cochlear synaptopathy. Did HEI develop a method to diagnose cochlear synaptopathy in alive humans? Are you able using your diagnostic methods to say that certain individual has damaged synapses?

      According to my last year discussion with Massachusetts Eye & Ear Infirmary researcher till now there was no reliable method to diagnose cochlear synaptopathy in alive humans, it was possible only post mortem. If you managed to find one it means a big step forward in our understanding of inner ear dysfunctions.
       
    12. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      I stated nothing as fact. I used the word presumably. If I'm wrong about Oblato then so be it. That does not change Oblato, the new partner, requiring a proof of concept for it to study the pill against tinnitus.

      "The reason we need to raise more money for a proof-of-concept study is to show 1) tinnitus can be tested objectively, demonstrate the cost of doing so, show that it can be successful, and illuminate the target demographic of those who suffer from tinnitus."

      To show tinnitus can be tested objectively means you need bio-markers. Something to physically identify tinnitus. Nobody has that. That's the single hardest part in tackling this condition. You get that and it's simply a matter of time until this is cracked. You get a true biomarker and you will have your golden ticket. Yes, word scores for speech in noise and general hearing tests, but not all who have tinnitus have hearing loss. The target demographic is already illuminated.

      As far as I'm concerned you're still at square one, and this partner is a side avenue.

      Like I say, if you get FDA approval for the cochlear implant trauma, you will very quickly have the tinnitus community buying this pill and letting you know if it works or not.

      Bottom line, I was rooting for Hough Ear Institute in a big way. But setback after setback and then some kind of false excitement really sours it.

      I don't mean to be a jerk about it. I respect you for fighting the good fight. But I'm pissed. I'm suffering and I'm fresh out of patience.
       
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    13. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      You can have qEEG brain mapping, it shows level of neuronal activity in the auditory cortex. The ones with tinnitus have it hyperactive. My qEEG shows hyperactivity and it's the only marker that shows I have tinnitus; hearing tests, otoemissions, ABR all are ok.
       
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    14. Joly

      Joly Member

      Tinnitus Since:
      22/08/2019
      Cause of Tinnitus:
      Traumatisme sonore
      @Mentos

      When you say the treatment repairs nerve endings, are you talking about the auditory nerve?
       
    15. AUTHOR
      AUTHOR
      all to gain
      No Mood

      all to gain Member

      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      Off topic a little, but how can one tell if the auditory nerve has been damaged? An ENT said mine probably was and that the hair cells probably hadn't been affected. No idea how she 'knows' this though.
       
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    16. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      Just confirming that my Loretta qEEG indeed also demonstrated hyperactivity in my auditory cortices. It’s a strong indicator of tinnitus.

      Researchers say that we need objective biomarkers, but there must be something that can already be used today to demonstrate efficacy during clinical trials.

      If the solution works, this should be visible on some types of scans that reveal reduced hyperactivity along the auditory pathway. Is it not possible also to verify hyperactivity in the cochlear nucleus?
       
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    17. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      What is the sensitivity and specificity of that test or is that unknown?
       
    18. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      @brokensoul, this study seems to imply that EEG changes occur only with tinnitus distress and not having tinnitus. I.e. mild tinnitus did not show changes. Do we know if rodents have tinnitus distress?

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4364116/

      Also, interestingly, if I am reading this right they found that the brain changes associated with tinnitus in this study occurred with hearing loss over 8000 Hz (and only in those higher frequencies) and that the hearing loss itself may account for those changes.
       
    19. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      That's my understanding that auditory nerve endings and synapses should be repaired, but better to ask @Justin De Moss.
       
    20. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      Based on what I was informed by brai3n.com who analyzed my qEEG it's not distress alone, I have it mild and consider myself quite habituated, still the qEEG indicates I have tinnitus.
       
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    21. HootOwl

      HootOwl Member Podcast Patron Benefactor Advocate

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      People somehow got their hands on Trobalt (which had far more serious side effects) so I’m confident most doctors would feel safe providing this off label since it’s just a potent anti-oxidant.

      I’ve already asked a few and they said if the phase 1 data showed it was safe they have no issue.

      After reading the press release and reevaluating the current state of the pill, I’d rather get this thing to market sooner than draw out the approval process by having a phase 2b for tinnitus. Unless that phase 2b ran concurrently with phase 3 for the cochlear implant trauma. Otherwise - let’s just assume it is effective for acute cases and the chronic cases can asses efficacy once it can bought.
       
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    22. Hazel
      Dreaming

      Hazel Director Staff Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      the Netherlands
      Tinnitus Since:
      10/2017
      Cause of Tinnitus:
      one-sided hearing loss (of unknown origin)
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    23. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      I just went to Brai3n (Dr. De Ridder) and they did a Loretta qEEG test (with eyes closed and ear protection). Afterwards they showed me the results and it contained a brain image with 1) hyperactive auditory cortices and 2) another zone that was underactive.

      It also confirmed brain wave anomalies (alpha, beta, gamma and delta band anomalies). I don’t know if this is common for tinnitus. Perhaps the severity of the anomalies is related to VSS. My tinnitus is also not mild.

      It’s probably not the most sensitive test you can do. It’s fairly basic as far as I know.
       
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    24. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      Just want to add that it also included functional connectivity results (brain regions that communicate which each other). It’s the test which shows red lines for communicating regions. The report also contained signal generation by several brain regions (don’t recall what it is called) and this demonstrated that I have thalamocortical dysrhytmia. The strength of the signal was too low or deviated significantly from the norm. It’s like an electrical pulse, but my pulses are abnormal. This is what I correlate with the weird feeling I have in my brain.

      I have asked this question before, but never got an answer. Is there anyone who has done such a test with similar results, but only has tinnitus (and not VSS)?

      @Mentos, what were your results?
       
    25. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      More or less same as yours. I have only tinnitus. No visual snow.
       
    26. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      Did Dr. De Ridder tell you that you have thalamocortical dysrhythmia?
       
    27. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      It was Jan Ost I talked to via Skype, I don't think he mentioned thalamocortical dysrhythmia.
       
    28. Momme

      Momme Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Loud noise?
      How do you get that? Thru noise induced or something else?
       
    29. brokensoul

      brokensoul Member

      Location:
      Belgium
      Tinnitus Since:
      02/05/2019
      Cause of Tinnitus:
      unknown:medication,cannabis,stress,sleep deprivation
      Tinnitus has been described as a thalamocortical dysrhythmia of the auditory pathway.

      Visual Snow Syndrome has been described as a thalamocortical dysrhythmia of the visual pathway, but this syndrome usually includes tinnitus as well for most people with VSS, so in reality it’s a thalamocortical dysrhythmia of the visual and auditory pathway.

      The qEEG done by the Brai3n clinic in Belgium confirmed this for me, although this was not really discussed.

      https://en.m.wikipedia.org/wiki/Thalamocortical_dysrhythmia

      Thalamocortical Dysrhythmia: A Theoretical Update in Tinnitus
      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4460809/

      I have no idea what caused my condition.
       
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    30. FGG
      No Mood

      FGG Member Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Forgive me if this is too off-topic but...

      What Neuro transmitters does he propose are involved in this dysrhythmia? There may actually be a way to treat this pharmacologically.

      There is (was? He was very old a decade and a half ago) a Nobel prize for medicine nominated doctor in Venezuela named Fuad Lechin whose life's work involved measuring serial levels of serotonin, Norepinephrine, Epinephrine and Dopamine etc at rest, orthostasis, light exercise, etc. and then figuring out how to pharmacologically tweak these levels to affect brain function and dysfunction, immune function (most people do not think the brain influences the immune system directly but he has shown that it does), etc.

      I don't know if it's still the case, but he was once the only one in the world to treat people at a clinical/hospital level with this approach (it took very precise dosing).

      I have his book. It's called Neurocircuitry and Neuroautonomic Disorders and he uses neurotransmitter tweaking to shift the immune system from TH-1 to TH-2 or vice versa. What's especially interesting here is he has profiles for "uncoping stress" and "endogenous depression" too. Since stress alone can, in some cases, lead to VSS, I wonder if this approach could help.

      Worth nothing that he didn't mention the thalamus specifically in his book but I will include a photo below of the kinds of trends he saw in those measurements.

      When I was there in 2004 (long story), he was training some German doctors in his method and i wonder if there would be a way to find them and ask them if something like this could help. This is super left field I realize but if VSS is truly a result of brain dysregulation in some cases (esp in those who have no cochlear damage), perhaps it can be treated as such.
       

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