Repeated Modified Nerve Blocks and Auditory and Non-Auditory Nerve Stimulation

[Freerunner]

I just got an email from Dr. De Ridder. He said that he is considering to offer this treatment at his clinic, but has some reservations about the design of the study (possible bias).

Did he give you more information such as some time frame? Did he mention anything else?

 

[Aussie Lea]

I just got an email from Dr. De Ridder. He said that he is considering to offer this treatment at his clinic, but has some reservations about the design of the study (possible bias).

Dr. De Ridder is AWESOME!!! Always willing to try more treatments it looks like.

How worrisome is the possible bias in the study?

 

[bill 112]

I'd like to see how this possibly helps hyperacusis/noxacusis too but, after reading through his response, I'm a little confused.

He says he treated chronic sufferers successfully but then he also goes on to say that having tinnitus for a long time i.e. chronic tinnitus reduces likelihood of good results, if any. I guess when he says chronic, he means around 6 months, to a year tops maybe? Good question to ask.

I'd be up to do this treatment if he's genuine or if it can be done closer to home. My tinnitus is heavily somatic so pushing my jaw greatly increases the volume so it might be worth a shot but then it might also be a risk too.

 

[OptimusPrimed]

I'd like to see how this possibly helps hyperacusis/noxacusis too but, after reading through his response, I'm a little confused.

He says he treated chronic sufferers successfully but then he also goes on to say that having tinnitus for a long time i.e. chronic tinnitus reduces likelihood of good results, if any. I guess when he says chronic, he means around 6 months, to a year tops maybe? Good question to ask.

I'd be up to do this treatment if he's genuine or if it can be done closer to home. My tinnitus is heavily somatic so pushing my jaw greatly increases the volume so it might be worth a shot but then it might also be a risk too.

Sounds like it all could be natural healing that may also have happened without intervention. Only something like 2-5% of cases are chronic.

Not holding my breath on this one, especially given the location of the treatment. It's basically unattainable for North Americans.

 

[bill 112]

Sounds like it all could be natural healing that may also have happened without intervention. Only something like 2-5% of cases are chronic.

Not holding my breath on this one, especially given the location of the treatment. It's basically unattainable for North Americans.

I hate any treatment that proves to be "effective" during the acute phase. How do they know it wasn't just a natural reduction? When I first got tinnitus in 2011, it was a loud hiss that reduced to a barely audible hiss over the course of a year. When I got hyperacusis in 2014, my tinnitus was screaming but both reduced greatly over a year to the point that my tinnitus was back to its previous level but some mild/moderate hyperacusis remained.

Seeing real improvement or a reverse of symptoms in chronic sufferers is what would get my attention. If they're targeting primarily new sufferers then it doesn't really peak my interest unless we learn more about his chronic patients and/or if it helps hyperacusis or not.

Watching this space but not getting my hopes up.

 

[Freerunner]

Sounds like it all could be natural healing that may also have happened without intervention. Only something like 2-5% of cases are chronic.

Not holding my breath on this one, especially given the location of the treatment. It's basically unattainable for North Americans.

You can have a look at charts. There are people with chronic tinnitus from 1 to 10 years who are documented in the study. Duration (years) is listed in the first column alongside with age and gender.

 

[PeterPan]

Please could you clear up what you mean exactly by duration/age?

If what you are saying is that the therapy works well with little regard to the age of the patient — that's good.

If what you are saying is that it works well with little regard to the duration of onset of the tinnitus — that's biiii...iiiig. In other words, it can alleviate chronic tinnitus. Almost too good to be true.

Well, the article states:

Age and tinnitus duration were also associated with poor clinical outcomes because of the likelihood of chronic maladaptive neuroplasticity and complex causes (for example, age-related hearing loss, cochlear cell degeneration, or psycho-emotional pathology) of auditory and non-auditory systems. Therefore, tinnitus should be treated as early as possible after its onset because auditory maladaptive neuroplasticity refractory to the treatment occurs ≥3 months after tinnitus onset.

And the response to @Uklawyer's questions were:

And severe hearing loss (who need hearing aids), heavy alcohol consumption, chronic heart and kidney diseases, diabetes and long tinnitus duration are poor prognostic factors.

But if you look at the 40 patients wich chronic tinnitus who participated in the study, this doesnt align with the above, i.e. those with long duration tinnitus didn't fare any worse than those with short duration...

Something to bear in mind is that there is no treatment that works for tinnitus yet there have been thousands of mooted candidates...

 

[Chinmoku]

Well, the article states:

Age and tinnitus duration were also associated with poor clinical outcomes because of the likelihood of chronic maladaptive neuroplasticity and complex causes (for example, age-related hearing loss, cochlear cell degeneration, or psycho-emotional pathology) of auditory and non-auditory systems. Therefore, tinnitus should be treated as early as possible after its onset because auditory maladaptive neuroplasticity refractory to the treatment occurs ≥3 months after tinnitus onset.

And the response to @Uklawyer's questions were:

And severe hearing loss (who need hearing aids), heavy alcohol consumption, chronic heart and kidney diseases, diabetes and long tinnitus duration are poor prognostic factors.

But if you look at the 40 patients wich chronic tinnitus who participated in the study, this doesnt align with the above, i.e. those with long duration tinnitus didn't fare any worse than those with short duration...

Something to bear in mind is that there is no treatment that works for tinnitus yet there have been thousands of mooted candidates...

Could they be referring to the 13% who didn't benefit from treatment? But their detailed chart shows success across the board.

I'm wary of unintentional selection bias. People with tinnitus normally visit ENTs. People with other pain problems and also tinnitus might visit a pain clinic and get tinnitus treated there. However, the causes for tinnitus of someone visiting a pain clinic have maybe less to do with hearing loss, cochlear hair cell degeneration etc, and might be more related to nerves?

No, it doesn't make sense. They treated 1000 people across 15 clinics. Perhaps they are referring really to the 13% who didn't benefit.

So they are saying: our technique works also for some of those cases (hearing loss etc), but almost all the times it didn't work, it was for patients with severe hearing loss etc. An attempt to explain the 13%?

 

[David S]

Hopefully we have 8-10 tinnitus clinics in Europe and USA looking into this right now. I wounder if we could ask if they have got concrete discussions with other clinics outside of South Korea to implement this treatment.

 

[Chinmoku]

Hopefully we have 8-10 tinnitus clinics in Europe and USA looking into this right now. I wounder if we could ask if they have got concrete discussions with other clinics outside of South Korea to implement this treatment.

I reached out to several UK specialists, in different areas. They wish to remain anonymous but they said that the needles would have to be approved by the EU, the treatment would have to receive ethical approval and before the NHS made it available they would need a multi-centre clinical trial. This is going to take years. We need to ask very high level people, like the president of the neuro-otologist society. Ironically this is what the BTA and ATA should be doing, not us. Perhaps we could contact Action on Hearing Loss? They seem more proactive.

The private sector has not been very responsive either. Although they have less constraints, they would take a big risk and no one I contacted so far is willing to do it. I'll keep trying. If others try, perhaps we can stumble in some positive response.

Specialists to contact:

• Pain surgeons, especially facial pain
• Maxillofacial surgeons
• Plastic surgeons
• ENT surgeons

Note that as soon as you mention tinnitus the other specialists will bounce you to an ENT. So it is important to make clear from the very start that this is an atypical treatment for tinnitus that may require skills beyond those of some ENTs.

I'll continue to try even in the middle of this excruciating electric noise.

 

[Uklawyer]

I'll continue to try even in the middle of this excruciating electric noise.

@Chinmoku, thanks for contacting specialists in the UK. I am a little confused, however, about approval of needles and clinical trials. This is nothing new.

I would have thought that pain specialists are the best bet. It is just a nerve block, which, I would have thought, is common practice for neuralgia. The needle, I thought, is just thinner than ones that are commonly used.

Did you try our ENT professor that we have both seen?

 

[Chinmoku]

@Chinmoku, thanks for contacting specialists in the UK. I am a little confused, however, about approval of needles and clinical trials. This is nothing new.

I would have thought that pain specialists are the best bet. It is just a nerve block, which, I would have thought, is common practice for neuralgia. The needle, I thought, is just thinner than ones that are commonly used.

Did you try our ENT professor that we have both seen?

He is no longer the president of the neuro-otology society but I will contact him. I had contacted his collaborator.

I will contact the new president too.

The board is here:

http://www.bsno.org.uk/MeetTheCommittee.html

I will also contact pain specialists. I had contacted one but he immediately bounced me back to an ENT surgeon.

Let's send both a letter.

 

[Jack Straw]

I hate any treatment that proves to be "effective" during the acute phase. How do they know it wasn't just a natural reduction? When I first got tinnitus in 2011, it was a loud hiss that reduced to a barely audible hiss over the course of a year. When I got hyperacusis in 2014, my tinnitus was screaming but both reduced greatly over a year to the point that my tinnitus was back to its previous level but some mild/moderate hyperacusis remained.

Seeing real improvement or a reverse of symptoms in chronic sufferers is what would get my attention. If they're targeting primarily new sufferers then it doesn't really peak my interest unless we learn more about his chronic patients and/or if it helps hyperacusis or not.

Watching this space but not getting my hopes up.

I think researchers / pharma companies know this about tinnitus and use it to their advantage. We can never distinguish between natural early healing vs actual effective treatment, especially without control.

If a drug worked for people who had tinnitus for 3-5+ years, I would think it was more legitimate.

 

[DoesItStop]

The people at this pain clinic responded back to me and said that if your tinnitus resulted from taking an ototoxic med like mine did (from Elavil), their treatment is typically ineffective.

So that's unfortunate, but at least they were honest.

 

[Uklawyer]

The people at this pain clinic responded back to me and said that if your tinnitus resulted from taking an ototoxic med like mine did (from Elavil), their treatment is typically ineffective.

It would be nice if if someone took the risk of venturing an explanation as to why something would or would not work. I would have thought ototoxicity-induced would have been a prime candidate.

Perhaps ask them the question?

 

[UKBloke]

If a drug worked for people who had tinnitus for 3-5+ years, I would think it was more legitimate.

Couldn't agree more. This for me is the most important point.

 

[David S]

The people at this pain clinic responded back to me and said that if your tinnitus resulted from taking an ototoxic med like mine did (from Elavil), their treatment is typically ineffective.

So that's unfortunate, but at least they were honest.

What type of tinnitus do you have? Head/ears? Pure tone or more unstable?

 

[David S]

What do you say about tinnitus camp in South Korea? Should be room for 200-300 international patients per year?

If we got any of the big tinnitus scientists on this (like Dr. De Ridder), we might be able to ask the clinic for a mini study with an external person review and collect all data. To collect data from 30-50 patients would not take more than 3-6 months. A perfect job for a graduate that have interest in this subject.

 

[scotty03874]

The people at this pain clinic responded back to me and said that if your tinnitus resulted from taking an ototoxic med like mine did (from Elavil), their treatment is typically ineffective.

But it may work if tinnitus is caused by a trauma to the ear? Like me, a slap to the ear...

 

[Padraigh Griffin]

The people at this pain clinic responded back to me and said that if your tinnitus resulted from taking an ototoxic med like mine did (from Elavil), their treatment is typically ineffective.

Only one patient in the study had an etiology of ototoxicity and their VAS went from 10 to a 5 one year post treatment. 15 sessions in total. So I would say not a total bust.

Ototoxicity is hard to summarise or link. It is well known that SSRIs are not ototoxic (in they don't damage the mechanisms of the inner/middle ear or cause hair damage) but yet are tinnitus provoking. They cause hyperexcitability in the DCN.

 

[Chinmoku]

There are some inconsistencies between the study and their claims. @Peter Pan pointed this out too.

The study claims 87% success with average improvement of 7/10, which is hugely successful compared to any other therapy. However, when questioned, they say it doesn't work well for ototoxic drugs, it doesn't work well for cochlear degeneration, it doesn't work well with heavy hearing loss, it doesn't work well with heart conditions etc. When does it work then? In their extended table, for the 55 patients, if I counted properly I found:

• 4 Neck
• 2 TMJ
• 1 Trauma
• 1 Ototoxic (reduction from 10 to 5 after one year, so it did work)
• 47 Idiopathic

They have one ototoxic success (I would say VAS going from 10 to 5 is a pretty good success) but they claim it doesn't work for ototoxic patients. Does that mean they tried it on other ototoxic patients and it didn't work? But then they claim that over the years the percentage of success remains roughly the same, which means that either it works for ototoxic drugs, or that they don't take ototoxic tinnitus patients.

Now the big question is, what are the idiopathic ones? And do they represent a good mix of tinnitus sufferers or are they all related to neck/TMJ? Because in the general population, I think that:

Ototoxic drugs+ cochlear degeneration + hearing loss + heart conditions + alcohol > 13%?

So in a way the study population does not seem to reflect the general population, where most tinnitus is due to loud noise and does involve cochlear damage and hearing loss. What would be the general population percentage of success then? What they write is perhaps to manage expectations of clients, but from what they reply I would expect a success rate of 40-50% max in the general population, not 87%. Something is amiss here. Unless they selected clients that have the "right" type of tinnitus for their treatment, or maybe even the clients self-selected because of the type of clinic.

So it's quite confusing. Does this treatment work mostly for tinnitus that is caused by neck problems and TMJ and without hearing loss? That would hardly be 87% in the general population.

 

[Bambam0]

So it's quite confusing. Does this treatment work mostly for tinnitus that is caused by neck problems and TMJ and without hearing loss? That would hardly be 87% in the general population.

Someone might be able to state this more scientifically but...

I wonder if this treatment worked "most" of the time because of the DCN theory that regardless of how it originates, tinnitus is the generated in the DCN and that soothing the auditory nerve "pathway" with Lidocaine eases the "misfirings"?

 

[Uklawyer]

Now the big question is, what are the idiopathic ones?

What was the % success for the idiopathic category? If that is high, I think you could extrapolate success for a range of issues. Acoustic trauma would be the outlier. I think that needs to be asked as a separate question.

 

[Chinmoku]

Someone might be able to state this more scientifically but...

I wonder if this treatment worked "most" of the time because of the DCN theory that regardless of how it originates, tinnitus is the generated in the DCN and that soothing the auditory nerve "pathway" with Lidocaine eases the "misfirings"?

I was thinking that by alternating stimulation and blocks the treatment might be sending some reset signals through the nerves to the dorsal cochlear nucleus, but I am not a medical doctor, so this might be totally bollocks. If this is the mechanism then it wouldn't matter that much what was the original shock, it would work anyway and even in presence of hearing loss.

What was the % success for the idiopathic category? If that is high, I think you could extrapolate success for a range of issues. Acoustic trauma would be the outlier. I think that needs to be asked as a separate question.

Most of the population in the study is idiopathic, so I would think the success rate among those is high. But I am really wary of selection bias, even self-selection bias by patients.

 

[DimLeb]

I believe that if the treatment works on idiopathic cases, then it can potentially work on most or all sub-categories of tinnitus. I imagine that in idiopathic tinnitus, there is some damage that cannot be located or defined by tests in the inner ear that leads to the hyperexcitability which the brain translates as noise.

I think that all other causes of tinnitus (acoustic trauma, hearing loss, ototoxic substances, TMJD etc) really are bigger and more obvious damage to the inner ears. And since the severity of tinnitus isn't proportional to the ear damage/cause (for example, acoustic trauma may cause mild, moderate, severe or no tinnitus), one can say that treating tinnitus could be totally detached from the cause.

So, if this is not a total scam or placebo, every patient could potentially benefit from it.

 

[Bambam0]

But I am really wary of selection bias, even self-selection bias by patients.

This. I feel like this is why the study results are so incredible. If it *actually* works, it probably does so for most cases.

 

[Chinmoku]

It may also be that they didn't expect this massive reaction, their article to become the most popular of that journal virtually overnight, to be flooded by emails and calls and now they are scared and trying to manage expectations, but the data are correct. This is the best scenario. The mechanism resets tinnitus whatever its origin, but they are scared by the response so they are being conservative.

The negative scenario is massive self selection bias.

I don't think it's a scam. It's a clinic in the centre of Seoul with a good business and client base. They treat many other conditions. What do they have to gain from publishing an article in English? They are not academics. They don't need to do this for a living. Actually it could give them more pain than anything, because it exposes them reputationally.

My impression is these guys stumbled on this technique, tinnitus is not their field, but after a while they realized the epidemic and the suffering, and decided to share their techniques with the world.

 

[ajc]

It may also be that they didn't expect this massive reaction, their article to become the most popular of that journal virtually overnight, to be flooded by emails and calls and now they are scared and trying to manage expectations, but the data are correct. This is the best scenario. The mechanism resets tinnitus whatever its origin, but they are scared by the response so they are being conservative.

The negative scenario is massive self selection bias.

I don't think it's a scam. It's a clinic in the centre of Seoul with a good business and client base. They treat many other conditions. What do they have to gain from publishing an article in English? They are not academics. They don't need to do this for a living. Actually it could give them more pain than anything, because it exposes them reputationally.

My impression is these guys stumbled on this technique, tinnitus is not their field, but after a while they realized the epidemic and the suffering, and decided to share their techniques with the world.

I think deep down you know this won't be effective for most of us. You want to believe hard, I understand that.

I'm sure some people with 3+ year tinnitus will be going to Seoul sometime this year and we will see what happens. Placebo can still be at work but if a few people report incredible results, it's going to look better and better...

 

[Chinmoku]

I think deep down you know this won't be effective for most of us. You want to believe hard, I understand that.

I'm sure some people with 3+ year tinnitus will be going to Seoul sometime this year and we will see what happens. Placebo can still be at work but if a few people report incredible results, it's going to look better and better...

You may be right but 7/10 improvement cannot be placebo. Either it works or it doesn't. I don't think they lied. I put also some faith on the paper reviewers. This is not like the other Korean therapy with PRP injections. We have a peer reviewed study here. So maybe some bias. But outright lying I would exclude.

 

[Joeseph Stope]

Hey, I hope that none of you mofos out there have gone off to your travel agent and bought a ticket to South Korea.

For the past three days do you know which country tops to list for new infections of COVID-19?

Not the States. Not Russia.

It's ummm... shhhhh... South Korea.

https://www.worldometers.info/coronavirus/

Not one to derail the topic of a thread or that. See caption.

And then there's World War 3 or Cold War 2 to worry about...