Neurosoft Bioelectronics: Implantable Electrodes to Treat Tinnitus

[addot]

Tinnitus perception is associated with hyperactivity in the auditory cortex and altered functional connectivity in the brain due to peripheral deafferentation in chronic tinnitus. Peripheral deafferentation leads to thalamic deactivation which in turn disrupts normal thalamocortical interaction. So, impossible to accomplish. No re-organization possible. There is no medication that can do this either. The only way is by sound therapies that are largely unsuccessful for most.

Why would reorganization be impossible? Just the simple fact that hearing aids suppresses tinnitus for some people shows that the brain does have the capacity to reorganize. Other treatments have shown the same (neuromodulation, brain/ear stimulation, etc). Kv channel activators also show promise, and they're medication. It's true that all these are still in early stages, unavailable to the general public, and may not help every single patient. It surely won't be easy, and they may end up not working at all, but I don't see how that indicates that it is impossible.

I'm not sure I understand the "late 2023" deadline here.

Is this deadline for when they will start to apply FDA for Phase 1/2/3 with their procedure?

The late 2023 deadline is for clinical proof of concept. This is done before any clinical trials to show that the treatment has enough promise (safety- and efficacy-wise) to be taken to trials. Phase 1/2/3 starts after that. In other words, this is a long way off.

 

[Tasty]

Tinnitus perception is associated with hyperactivity in the auditory cortex and altered functional connectivity in the brain due to peripheral deafferentation in chronic tinnitus. Peripheral deafferentation leads to thalamic deactivation which in turn disrupts normal thalamocortical interaction. So, impossible to accomplish. No re-organization possible. There is no medication that can do this either. The only way is by sound therapies that are largely unsuccessful for most.

So ultimately, how will this help the correct the maladaptative processes in the brain?

That's not entirely true. DBS is very successful in eliminating symptoms of Parkinson's, depression, neurogenic pain and so on that are all a form of thalamocortical dysrhythmia and, TCD can be treated with neurosurgical interventions as such as DBS. It's just not approved for tinnitus, that's another story, but hell yeah, TCD can be "reversed."

In high-frequency deep brain stimulation (DBS) a reversible lesion-like effect is mimicked. From findings in Parkinson's disease patients who also had tinnitus and were treated with DBS, it is known that stimulation can alter or even completely diminish perception of tinnitus.

I think that is "proof" enough that "chronic tinnitus can be reversed/eliminated" (but only with the right approach.)

 

[Ela Stefan]

The late 2023 deadline is for clinical proof of concept. This is done before any clinical trials to show that the treatment has enough promise (safety- and efficacy-wise) to be taken to trials. Phase 1/2/3 starts after that. In other words, this is a long way off.

Do clinical trials work faster for devices than for medications?

Reorganisation is impossible as of now. And the statement can be more in relation to multitonal and fluctuating tinnitus. It does show I think that more brain areas are involved, and is not just a quick fix of tonal frequency (corresponding to hearing loss).

 

[Ela Stefan]

That's not entirely true. DBS is very successful in eliminating symptoms of Parkinson's, depression, neurogenic pain and so on that are all a form of thalamocortical dysrhythmia and, TCD can be treated with neurosurgical interventions as such as DBS. It's just not approved for tinnitus, that's another story, but hell yeah, TCD can be "reversed."

In high-frequency deep brain stimulation (DBS) a reversible lesion-like effect is mimicked. From findings in Parkinson's disease patients who also had tinnitus and were treated with DBS, it is known that stimulation can alter or even completely diminish perception of tinnitus.

I think that is "proof" enough that "chronic tinnitus can be reversed/eliminated" (but only with the right approach.)

Compared with epilepsy, Parkinson's etc. where outbreaks of hyperactivity can be better isolated and perceived by tests, it is not that simple with tinnitus. Or there wouldn't be clinical trials trying to stimulate different stops of the auditory nerve or the auditory cortex itself.

 

[Christiaan]

Tinnitus perception is associated with hyperactivity in the auditory cortex and altered functional connectivity in the brain due to peripheral deafferentation in chronic tinnitus. Peripheral deafferentation leads to thalamic deactivation which in turn disrupts normal thalamocortical interaction. So, impossible to accomplish. No re-organization possible. There is no medication that can do this either. The only way is by sound therapies that are largely unsuccessful for most.

So ultimately, how will this help the correct the maladaptative processes in the brain?

That's one way to look at it, but there are many theories that explain the manifestation of tinnitus.

A theory that is broadly supported by neurologists is the Bayesian Brain Model, which explains that multiple brain parts are involved in the manifestation and perception of tinnitus, such as the dorsal cochlear nucleus, anterior cingulate cortex, the thalamus, the auditory cortex & the dorsolateral prefrontal cortex.

It's part of the explanation why some neurologists & clinical audiologists, like Dr. Shekhawat, think that manipulating the dorsolateral prefrontal cortex, which is not directly involved in the auditory pathway, can alter our perception of tinnitus because this part of the brain plays an important part in our awareness of interoceptive and exteroceptive stimuli (processing sensory signals internal/external state of the body). In other words, even disrupting just one part of the aberrant brain network could entail change in loudness/awareness of tinnitus.

Even though there are some differences between DBS & SOFT TINNIT, I think that Smit (2018) makes an interesting point why disrupting pathological activity in certain brain regions by means of electronic stimulation could help in decreasing loudness/awareness of tinnitus:

''The rationale behind the effect of DBS on tinnitus is mainly based upon the finding that DBS mimics a lesioning effect, thus decreasing hyperactivity in the pathological brain regions. Since it is unlikely that DBS only inhibits neuronal activity, the theory that DBS disrupts pathological activity seems to be more plausible.''

Link:
https://cris.maastrichtuniversity.nl/ws/portalfiles/portal/27840389/a6119.pdf

 

[Cory_]

I have this pulsating zap that feels like electricity shocking me. It's literally painful and random; happens several times a minute—often aggressively—and is impossible to habituate to, I fear, because of its randomness and the pain aspects of it.

Like hiccups from hell

 

[Jerad]

Like hiccups from hell

Do you have this too? If so, what brought yours on?

 

[Ela Stefan]

It's part of the explanation why some neurologists & clinical audiologists, like Dr. Shekhawat, think that manipulating the dorsolateral prefrontal cortex, which is not directly involved in the auditory pathway, can alter our perception of tinnitus because this part of the brain plays an important part in our awareness of interoceptive and exteroceptive stimuli (processing sensory signals internal/external state of the body). In other words, even disrupting just one part of the aberrant brain network could entail change in loudness/awareness of tinnitus.

Is this one the Grenoble Deep Brain Stimulation trial for tinnitus?

 

[Christiaan]

Is this one the Grenoble Deep Brain Stimulation trial for tinnitus?

No, Dr. Shekhawat works with non-invasive devices, like rTMS & (HD) tDCS.

Here's an example of one of his studies:

Optimization of Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex for Tinnitus: A Non-Linear Dose-Response Effect

Another thing worth noting is that he's currently conducting a new trial with HD-tDCS for tinnitus in Australia:

The high-tech headset that could silence tinnitus for good

 

[Cory_]

Do you have this too? If so, what brought yours on?

No, thank god. Not yet, anyhow.

 

[GuitarMan]

They don't know or can't prove where tinnitus originates from. They believe it is caused by a lack of auditory input which causes the brain (auditory cortex) to become hyperactive.

Does anyone know how this would work? My tinnitus tone is at approx 10.5 kHz but if I play a 10.5 kHz tone I can hear it just fine even in my left ear which is the one with mild hearing loss. It sounds lower in volume than it does in my right ear but I still hear it. So if I'm still getting the auditory input at that frequency, how would that explain tinnitus with this hypothesis?

 

[EDDTEKK]

Dr. Dirk de Ridder had tried in the past to attach electrodes to the auditory system to eliminate tinnitus. It failed.

Does this device differ much from that? I wonder because he is part of the organization team. Do they really believe in this approach? Normally they should test first in animals like apes, for example.

 

[Gb3]

Dr. Dirk de Ridder had tried in the past to attach electrodes to the auditory system to eliminate tinnitus. It failed.

Does this device differ much from that? I wonder because he is part of the organization team. Do they really believe in this approach? Normally they should test first in animals like apes, for example.

Actually attached to the brain or on the outside of the head? This is a brain implant.

 

[OptimusPrimed]

Dr. Dirk de Ridder had tried in the past to attach electrodes to the auditory system to eliminate tinnitus. It failed.

Does this device differ much from that? I wonder because he is part of the organization team. Do they really believe in this approach? Normally they should test first in animals like apes, for example.

Dr. Dirk De Ridder also said that hearing aids don't help with tinnitus but we know that in a lot of people both cochlear implants and hearing aids silence it for some people.

Hell, I can turn on some neuromodulation videos on YouTube and get silence for a few minutes. I take what that guy says with a grain of salt... not the word of god.

 

[EDDTEKK]

Dr. Dirk De Ridder also said that hearing aids don't help with tinnitus but we know that in a lot of people both cochlear implants and hearing aids silence it for some people.

That not correct. He said it helps 30% of the patients. I have friends who tried hearing aids for tinnitus and they didn't help them much. There might be some tinnitus patients who benefit from hearing aids, but seems to be rare.

 

[Nick47]

"These results are very promising as the unique properties of these electrodes could allow for brain insertions in areas where no other implant can safely be inserted today, opening the door to treating indications such as severe tinnitus with no existing cure or validated treatment."

Safer and more Effective Brain Interfaces: First in Human Brain Recordings Achieved by Neurosoft Bioelectronics

 

[ErikaS]

"These results are very promising as the unique properties of these electrodes could allow for brain insertions in areas where no other implant can safely be inserted today, opening the door to treating indications such as severe tinnitus with no existing cure or validated treatment."

Safer and more Effective Brain Interfaces: First in Human Brain Recordings Achieved by Neurosoft Bioelectronics

So much talk about tinnitus in that article, I hope at least one of the 10 participants they speak of in the upcoming months has tinnitus!

 

[ploughna]

Even if it still has a ways to go (!), this is an exciting update. The technology could be a genuine gamechanger and, frankly, a treatment I'd have a lot more confidence in than Neurolink...

 

[Nick47]

So much talk about tinnitus in that article, I hope at least one of the 10 participants they speak of in the upcoming months has tinnitus!

The company mention tinnitus more than almost any other company I've heard of, rather than drop it in casually once. Earlier in this thread I think someone mentioned that they were aiming to start testing the SOFT TINNIT at the end of 2023, so hopefully some of those 10 participants will have severe tinnitus.

A Swiss company, yet they talk about FDA approval?

 

[ErikaS]

The company mention tinnitus more than almost any other company I've heard of, rather than drop it in casually once. Earlier in this thread I think someone mentioned that they were aiming to start testing the SOFT TINNIT at the end of 2023, so hopefully some of those 10 participants will have severe tinnitus.

A Swiss company, yet they talk about FDA approval?

I appreciate you posting about this because although I am speaking with MyTomorrows about advocacy for BHV-7000, I will certainly bring this up. Hell, I will fly there now to get that SOFT TINNIT in my head. Feeling at the end of the rope these days.

I noticed that too about FDA approval. I wonder if their plan is to launch first in the USA?

 

[Nick47]

I appreciate you posting about this because although I am speaking with MyTomorrows about advocacy for BHV-7000, I will certainly bring this up. Hell, I will fly there now to get that SOFT TINNIT in my head. Feeling at the end of the rope these days.

I noticed that too about FDA approval. I wonder if their plan is to launch first in the USA?

My tinnitus is horrendous today. Both ears going bananas. I think you are very proactive and it's the only way. No idea on the FDA but they may see it as the biggest market.

 

[ErikaS]

I have a Zoom call this coming Thursday with Dr. Nicolas Gninenko, their Clinical Neuroscientist, to share my story and to hear about their vision forward with SOFT TINNIT. This Zoom invitation came after I simply sent an email back in the beginning of October speaking generally about my current condition and debilitated state, saying how appreciative I and many are of their work, asked about future clinical trial, etc. Not only did he provide some general information in return, but he was so kind to ask me to join him on a Zoom call.

After looking him up, Dr. Gninenko's history of work and research is immersed in tinnitus. He seems to be very driven to discover and be part of a solution to what debilitates so many of us. I am actually flattered he asked to talk with me after reading up on him.

I will take good notes and share after.

 

[Nick47]

I have a Zoom call this coming Thursday with Dr. Nicolas Gninenko, their Clinical Neuroscientist, to share my story and to hear about their vision forward with SOFT TINNIT.

Wow.

 

[ErikaS]

Wow.

I am already coming up with questions as you can imagine. But if you, or anyone else reading this, have like 1-2 top things you'd want to ask or know more about, just respond here and I will do my best to get a good amount of information for us!

 

[DimLeb]

I am already coming up with questions as you can imagine. But if you, or anyone else reading this, have like 1-2 top things you'd want to ask or know more about, just respond here and I will do my best to get a good amount of information for us!

It's surprising how willing and approachable he was, in comparison to many other researchers. This does have the potential to be a big thing for many with ear problems.

If you still have a room for a question, that would be: Have they thought if their device could help with any other symptoms (related to tinnitus), meaning hyperacusis, noxacusis, reactive tinnitus, TTTS/ear spasms, diplacusis, visual snow etc?

It's a long shot I know, but we often neglect that many people here suffer from a mixture of those and sometimes the tinnitus becomes the least of their problems (of course it would be amazing if tinnitus was gone!).

Anyhow, thank you for the contribution in our community! I hope you (and others here) see better days!

 

[Alberte]

I am already coming up with questions as you can imagine. But if you, or anyone else reading this, have like 1-2 top things you'd want to ask or know more about, just respond here and I will do my best to get a good amount of information for us!

Hello @ErikaS, here's my questions: Is there contraindication to the use of this treatment? When will it be available in USA?

 

[Gb3]

Did he provide any information regarding clinical trials?

 

[ErikaS]

It's surprising how willing and approachable he was, in comparison to many other researchers. This does have the potential to be a big thing for many with ear problems.

If you still have a room for a question, that would be: Have they thought if their device could help with any other symptoms (related to tinnitus), meaning hyperacusis, noxacusis, reactive tinnitus, TTTS/ear spasms, diplacusis, visual snow etc?

It's a long shot I know, but we often neglect that many people here suffer from a mixture of those and sometimes the tinnitus becomes the least of their problems (of course it would be amazing if tinnitus was gone!).

Anyhow, thank you for the contribution in our community! I hope you (and others here) see better days!

I agree! I thought the exact same thing, how mostly I get no response or short responses with no further conversation when I were to contact someone or a team. I will say I think he is mid 30s, so he may just be wanting to do his due diligence as part of this company (he joined the team in June 2022) as they get closer to taking a look at participants for future SOFT TINNIT trial.

Love your question, that is pretty much one I had as well due to my biggest debilitating factor being reactivity/sound reactive tinnitus. Transcranial electrical simulation spiked my reactivity, what would be the difference with SOFT TINNIT? Definitely worth asking those questions regarding debilitation factors other than just the tinnitus itself.

Did he provide any information regarding clinical trials?

This is what his initial email said:

Dear Erika,

First, apologies for the long delay and thank you for your touching testimony.

At Neurosoft Bioelectronics, we indeed aim at developing a novel minimally invasive solution to address chronic severe tinnitus. It is unfortunately a long process, but we do have several reasons to believe that such technology could soon alleviate the life of many living with this chronic disorder. As of today, we are still at an early stage regarding the first proof-of-concept in humans, but we are envisioning to collect interested people's contact information for further reach out.

In the meantime, we would be happy to hear more about your story, if this is something you would be willing to share with us over a Zoom call, as we particularly value such feedback.

Please kindly let me know if you would like to discuss and hear more about our vision.

 

[Nick47]

@ErikaS, @Markku, a Tinnitus Talk Podcast candidate?

I am already coming up with questions as you can imagine. But if you, or anyone else reading this, have like 1-2 top things you'd want to ask or know more about, just respond here and I will do my best to get a good amount of information for us!

@ErikaS, this is the guy you will be talking to.

It seems he has experience in tinnitus research.

You could ask him about:

• His findings on non-invasive stimulation. The best places to target?
• Does the hearing status of the patient change the type of surgery and expected outcome? For instance, I have profound hearing loss unilaterally.
• As we have both got sound reactive tinnitus, what's his thoughts on this. Nerve issues?

 

[Joeseph Stope]

The company mention tinnitus more than almost any other company I've heard of, rather than drop it in casually once. Earlier in this thread I think someone mentioned that they were aiming to start testing the SOFT TINNIT at the end of 2023, so hopefully some of those 10 participants will have severe tinnitus.

A Swiss company, yet they talk about FDA approval?

Well, just think for one moment: Switzerland population... not more than 10 million (I think). USA population... 330 million. Both are fairly good on the income per capita scale but the USA is really the prize. If they get FDA approval, it would easily open the door to other places like EU, UK etc.

But hey! implanting electrodes in the brain! Yay, I dunno! Would they have to surgically saw off a part of your skull to insert them? Has keyhole surgery come on enough to get the job done? That might be more palatable.