TU Delft & Prof. Dirk De Ridder — Bimodal Stimulation Device for Treating Tinnitus

Uhm... this is not Prof. De Ridder, but a Dutch sailor with the same name who represented my country at the 2000 Summer Olympics in Sydney and the one who was banned from 2013 America's Cup after being caught cheating during the America's Cup World Series in 2012 (Wiki).

 

Yes, but where is the published pre-clinical work? The article is vague, blasé and lazy. This is what has led to 'speculation' on here as we are trying to fill in the gaps.

 

The article is from a Dutch newspaper, not from a scientific magazine or journal where they evidently go through the specifics of a study.

I understand your question about the pre-clinical work. It's possible that this information isn't publicly available yet. I'd suggest reaching out directly to Prof. De Ridder or Prof. Serdijn for the most accurate details regarding their research publication status/research paper.

 

Haha - thanks.

 

I can't find a babysitter, unfortunately, so I won't be able to attend.

It's pretty interesting to see the amount of interest this device has already generated, though. Over the past couple weeks somewhere between 5 to 10 people have mentioned this research to me.

I don't think anyone ever mentioned anything tinnitus-related to me before over the past 4 years.

 

I've just returned from the symposium and, while time is tight and I won't be able to draft a detailed report (but hopefully in the near future), I wanted to share some key points here on Tinnitus Talk for everyone:

Presentation on DBS: Dr. Marc Janssen (University Maastricht)

Dr. Marc Janssen recently delivered an insightful presentation on the innovative use of deep brain stimulation (DBS) as a potential treatment for tinnitus. He highlighted various strategies for implanting DBS electrodes and shared that their team opted for placing electrodes within the medial geniculate body area of the brain. Dr. Janssen announced plans for a forthcoming human trial involving six participants, aimed at evaluating the safety & efficacy of this intervention.

Intriguingly, Dr. Janssen also revealed that a preliminary human pilot study has already been conducted, yielding promising results. The participant experienced a significant reduction in the severity of their condition. For instance, their Visual Analog Scale (VAS) score, a psychometric tool used to measure subjective experiences of distress, dramatically improved from 95 to 35. Other measures, including the Tinnitus Questionnaire (TQ), the Tinnitus Functional Index (TFI), and the Hospital Anxiety and Depression Scale (HADS), also indicated positive outcomes.

However, Dr. Janssen cautioned that the small sample size of the pilot study limits any definitive conclusions about the treatment's overall effectiveness. The anticipation grows for the upcoming clinical trial, which will provide a clearer understanding of how DBS might benefit additional patients suffering from tinnitus.








Presentation on the Tinnitus Delft device: Prof. Wouter Serdijn (TU Delft)

Professor Serdijn offered enlightening updates about the TU Delft device, a novel approach in the treatment of tinnitus, during his recent presentation. He emphasized the diversity of medical devices aimed at mitigating tinnitus, pointing out the unique aspects of the TU Delft device in comparison to others like Lenire and Dr. Shore's variant of the Auricle device. Prof. Serdijn detailed the device's design, which includes a robust casing enabling the adjustment of auditory frequencies and the timing of somatosensory stimuli. It also comprises headphones and electrodes specifically intended for placement on the auricular branch of the vagus nerve, as illustrated in the presentation slides depicting the ear's anatomy.

Towards the end of his talk, Prof. Serdijn outlined the forthcoming phases for the device's journey, including the clinical trial protocol set to be established in New Zealand, the process of obtaining METC approval for testing the device without a CE marking, and the anticipation of results by November 2024. This comprehensive overview not only showcased the innovative engineering behind the TU Delft device but also set the stage for its potential impact on tinnitus treatment pending further clinical investigation.

I asked Prof. Serdijn & Dr. De Ridder this question at the symposium. This is their response:

 

I would like to know what they think about the potassium channel openers. Is it too late to ask them about it?

Also, DBS is no child's play. Less invasive methods should be researched IMO. Many, many things can go wrong with it, this is not a basic mole removal op, they are going to drill into your skull and place an electrode in your brain, your body can reject it years down the line, the wires can cause infection and inflame the skin mandating another operation for the implant to be removed, etc. many things can go wrong with this, there are many stories online. I have ZERO trust in doctors doing a capable job like this on us anyways. Unless you have catastrophic tinnitus, I think most people shouldn't even consider this.

 

@Christiaan, thanks, you've done a great job. The DBS is good news, although sample sizes are very small overall.

As for TU Delft, I'm not sold. Not at all. If that was the reply to the pre-clinical work, it's complete bluster. None of them answered the question and waffled on about a load of nonsense. Enough said there.

There was nothing about the trial design:

• Number of participants
• Start date
• Placebo/control group
• Crossover or not
• Blinding
• Primary outcome measures

I noticed they compared it to Auricle, stating that this competitor reduces tinnitus distress. Something Dr. Dirk De Ridder said years ago in his podcast, almost trying to invalidate Dr. Shore's claims on loudness reduction.

 

I actually asked Dr. De Ridder about it, and he provided quite an extensive answer. I didn't have time yesterday to transcribe the audio recording of this particular moment, but I will do so sometime this week.

About DBS: Dr. Marc Janssen talked a considerable part of the presentation about the surgery protocol and how they use brain scans for precision work (to avoid blood vessels, etc.) before using the measuring instrument (as seen in the PowerPoint slide) for the implementation of two electrodes. Granted, this measuring instrument does look a bit archaic, especially when compared to the surgical robot that they use at Neuralink.

 

When it comes to pre-clinical work, I tend to agree with you that they haven't worked delicately, as previous versions of this device haven't been tested in animal studies, which is preferably the way to go.

Dr. De Ridder has conducted many experiments with bimodal stimulation (pre-clinical and clinical), but the main difference with previous devices is that they've now decided to use a different location of the vagus nerve (auricular branch of the vagus nerve instead of the left vagus nerve in the neck) for electrical stimulation. They've also chosen burst stimulation (intermittent) instead of tonic stimulation (continuous) and have decided to pair noise stimulation with tinnitus-matched sounds (instead of sound exposure excluding the tinnitus-matched frequency).

If we talk about burst stimulation specifically: this technique has already been experimented with for VNS combined with tones having frequencies other than the tinnitus sound, and it has not demonstrated to be superior to simple VNS.

However, in this case with the TU Delft device, regarding sound stimulation, the sound frequencies match those characteristic of the tinnitus. The rationale for this approach is that pairing a tinnitus-matched tone with relaxing electrical burst vagal nerve stimulation can reduce the associated arousal of the tinnitus by removing the paradoxical salience attached to the tinnitus tone. Thus, neuroplasticity may significantly contribute to altering the neuronal connections and firing rates, thereby inhibiting the activity of neurons that generate the tinnitus frequencies

Concerning the trial design: that's certainly a good point. They did mention it in a radio interview, but it's beyond me why they haven't discussed it at the symposium. I hope to raise this question at a webinar meeting with Dr. De Ridder tomorrow evening.

I also agree that they shouldn't have grouped Lenire, MicroTransponder, and Auricle together as similar machines on that presentation sheet. It's not intellectually honest of those who put this overview together. As for Dr. De Ridder, I haven't heard him being dismissive of Dr. Shore's research on tinnitus at the symposium. It's perhaps relevant to mention that I had a video consult with him about a year ago, and I remember him saying that he does believe that the Auricle device can reduce not just the distress caused by tinnitus but also its loudness.

 

I love what TU Delft wrote on the slide: "Safety was a priority in the design". I wonder what options they were choosing between and which were more and which less dangerous. I imagine stopping tinnitus by chopping the head off would be a dangerous way. On the opposite, there are sound and small electric stimulus. Since they are responsible and like people ($$), they went for the second option.

 

Hi @Christiaan, I'm interested in what he thought about the Kv7.2/3 openers.

 

Yes, just finished with the transcription. Here you go:

Note about the network stimulation in the last paragraph: I also attended a webinar featuring Dr. De Ridder on February 8th, where he had an interesting thing to say about an upcoming trial that involves a new network stimulation device for tinnitus. If you want, I could also write a transcription of this portion of the webinar.

I sent a few questions regarding the study design & (pre)clinical research of the TU Delft device to the organization (Stichting Hoormij) responsible for the webinar featuring Dr. De Ridder on February 8th. They replied that they would contact Dr. De Ridder and give an update as soon as possible.

 

Thanks for all your very informative posts, @Christiaan.

Did Dr. De Ridder happen to expand upon what a "Network Stimulation Device" should entail? Given the name, it sounds like it would stimulate various channels/factors, similar to Dr. De Ridder's medical cocktails – but through neuromodulation instead.

 

Thanks @Christiaan.

For me, Dr. De Ridder is taking us nowhere other than philosophy. His pre-clinical work is almost non-existent and his financial wealth ever increasing. This may sound harsh and indeed may actually be, however after 25 years of research and not a single treatment, it's time he departed the tinnitus community. I expect he has tried, especially earlier in his career, but ultimately lived off his hyperbole and became detached from research and driven by fanciful brain philosophy. His War on Tinnitus resolves around fanciful proposals with little research to back it up. A range of brain zapping techniques followed by a flower supplement. He's charismatic on show, when allowed to present unchallenged, however when probed and questioned I've seen him get defensive and political. He completely avoided and side-stepped away from the Kv7.2/3 channels.

He also appeared on the Tinnitus Relief Summit again and it was just a rehash of his usual crap!

He's not the only one. If I were Alan Sugar; Rauschecker, Vannaste, Tzounopoulos, Schlee and Langguth would all be fired. I accept that Tzounopoulos has perhaps found something significant in Kv7.2/3 channels, but 15 years of failure have followed.

Ultimately these gentlemen have earned good careers and left little imprint in significant findings and no treatments.

I expect the TU DELFT device will offer little to most people.

I would think it's multi-channel HD-tDCS.

 

Yes, he did, and you're also right about the stimulation part. Dr. De Ridder gave quite a lengthy presentation concerning this device, which is called Starstim 32. I'll send the transcription next week (maybe on Friday).

The upcoming trial will most likely involve one group with multitarget brain stimulation and another group with the combination of multitarget brain stimulation + psychedelics (MMDA/MDMA).

Interestingly, this is the very same device that he told me about when we had a virtual meeting on April 11th, 2022.

Here are pictures of three PowerPoint slides that I took during the webinar:

#1


#2


#3

 

Don't forget that DBS involves an MRI scan. They're insanely loud and some people have claimed it's spiked them. My scan didn't seem to affect my tinnitus, but I had a quieter machine.

 

What do you expect him to say? Oh, the Kv7.2/3 modulators work 100% to the point you won't have to use my device at all?

If the Kv7.2/3 openers would be enough, that would invalidate his decades old research into tinnitus, making his new device meaningless and he wouldn't be able to sell us anything.

I also don't understand how they could consider LSD to be a way to treat tinnitus. LSD is the number one reason why people end up with HPPD, along with tinnitus and depersonalization/derealization, meaning you would go insane and have visual disturbances on top of tinnitus. Tiny doses of LSD is enough to cause that.

 

@Christiaan, I hope I didn't come across as attacking you. I'm just frustrated by the way Dr. De Ridder goes about his development of treatment. It seems he has very little underpinning research for his models and treatment modality.

I think it is fantastic you attended and reported back for us.

 

As someone who has had tinnitus for several decades, and spent a lot of that time looking for a fix (in my case, and pretty much everyone else, it boils down to masking, keeping noise and stress down, etc), this has all the markings of yet another Rah Rah event where someone champions something or someone w/ no real scientifically proven clinical studies that happen over time. Until that happens, it's just talk.

This stuff is insidious, as mine has become more noticeable just typing this!

 

You're right about LSD, and the same goes for MDMA (though I'm not sure about MMDA). The PowerPoint slide appears to suggest that Dr. De Ridder plans to combine LSD with multi-target brain stimulation; however, this is not the case. He's actually planning to use MDMA and/or MMDA & electronic stimulation.

During that part of the presentation, he discussed psychedelics like LSD in general and how they help to boost neuroplasticity. He expressed hope that this enhancement of neuroplasticity would make the human brain more receptive to electronic stimulation, aimed at changing or reversing maladaptive plasticity.

 

I totally agree with @Nick47 and thanks @Christiaan for your summary. It seems Dr. De Ridder still has absolutely no clue with regards to tinnitus. Unfortunately, he is not alone...

Almost all of his treatments and trials have failed. He is a good show master and can talk about tinnitus for hours. But at the end of the day, he has no helpful advice at all. I wish he had. All the discussions I have had with him have been nonsense.

At least he hasn’t given up. He has attempted to search for new treatments. But he will probably not succeed in his life. There is too little support by the government and too few researchers on this planet.

Let’s hope Susan Shore’s device will have some effect. Even a 30% reduction would make me happy and feel cured.

 

Hello @Christiaan.

Dr. De Ridder's comments suggest that it will be difficult to find a single cure for tinnitus.

Tinnitus increases or worsens via the auditory inputs, the somatosensory inputs (trigeminal nerve, dorsal nerve, etc.), or even via the emotional pathway (sudden stress, for example).

This is what I notice in my case, where although the main cause is noise, my tinnitus is is also aggravated by connections with the trigeminal nerve, and I sometimes even have tinnitus attacks because of stress or a nervous condition.

Nobody here is a researcher, but reading the numerous scientific publications, can we think that the hyperactive zone is the cochlear nuclei, which would be linked to the somatosensory inputs, as well as various nerves in the head and neck, and possibly areas of our brain managing emotions?

In any case, thank you for your feedback.

 

I don’t see your remarks as a personal attack, but anyway, thanks for being so considerate I can also imagine that it might seem like I’m trying to defend Dr. De Ridder or cover for him; that’s not the case. I also value intellectual honesty, especially in the field of tinnitus research. And I, too, have my concerns about some of his work and theories. However, if we were to erase even the recent research performed by researchers like Dr. De Ridder, Dr. Rauschecker, or Dr. Tzounopoulos, would we have a better understanding of how tinnitus manifests in the brain?

If there's one thing that's certain, it's that progress in research often results from trial and error, and that's evidently a sluggish iterative process. This can be understandably frustrating for people who suffer daily from tinnitus and hope for something or someone to help speed up the process of finding a cure for this ailment.

From a certain perspective, it might seem as though we haven't made much progress in the last few years. However, a lot has changed when we consider the shift from viewing tinnitus as primarily an auditory cortex issue to a broader perspective that involves multiple components of the human brain. Dr. De Ridder and Dr. Rauschecker, despite some shortcomings—which we all have—have also made significant scientific contributions in that regard.

So I agree with you in some ways that Dr. De Ridder should reconsider some projects by looking at other avenues that may seem more advantageous or effective, but at the same time I think it's important to keep in mind that researchers like him, Dr. Vanneste and others have played an important part in (recent) tinnitus research and may continue to do so.

#1: The neuroscience of tinnitus: a historical perspective



#2: Several pathways involved in the manifestation of tinnitus



#3: Components of the brain that are likely to be involved in the manifestation of tinnitus

 

TU Delft has published videos of the symposium on YouTube in Dutch. You can use the automatic translation feature to follow the lectures:

Dr. De Ridder — Tinnitus: what is it and what can you do about it?

Tinnitus: wat is het en wat kun je er tegen doen?

Dr. Serdijn — Technology that leaves you speechless: A device against tinnitus

Technologie waar je stil van wordt: Een...

Joop van Gent (MSc.) — Tinnitus House: How can we better understand tinnitus?

Het Tinnitus House: Hoe kunnen we Tinnitus...

 

Yes mate, and an example would be extracochlear electrical stimulation that Dr. Carlson and Dr. Hamid Djalilian are doing. If he is working with a technology giant like TU Delft and he's looked at the success of pilot trials, he would see the opportunity. It's like oh, it's the middle ear and I'm the brain, so not interested.

I think he is so entrenched in the whole brain network model he can't look at what else is happening. I thought the answer to the Kv7.2/3 channel question was bollocks. He moved away from it as soon as possible and switched to talking about cocktails.

 

Another article has been published today by a Dutch newspaper (NRC) about the TU Delft device. Most of the text is perhaps old news, but there are some things that might be interesting.

Here are the takeaways from the article:

• The upcoming clinical trial will take place at the university of Otago.
• The trial will start in April and the initial outcomes will be expected in October/November.
• The trial consists of three groups of thirty people.
• One group receives paired simulation: sound and pulses simultaneously.
• The second group receives the sound and pulses uncoupled.
• The third group receives the sound and pulses coupled, and additionally, they will also stimulate the brain with electro-pulses at the endpoint of the vagus nerve in the brain.
• Statement Dr. De Ridder concerning the trial design: ''We expect little results from group 2, because the decoupling will not induce any learning," says De Ridder. "We expect results from both group 1 and group 3. If group 1 works sufficiently, then group 3 is unnecessary. But if we see only partial improvement in group 1, then it might work better in group 3''.

Here's a summary of the article 'Getting Rid of the Maddening Tinnitus with a Clip and Headphones' by ChatGPT:

→ Source

 

Dunedin is beautiful, in case anyone was planning a visit.

 

There was a university in the US that did trials on vagus nerve stimulation (implant) combined with sounds. The name was "MicroTransponder" back in 2011 or so.

The results showed not much success, otherwise they would have continued with that approach. I never heard again from any additional trials.

The TU Delft device is not very different except that it is not invasive. They will stimulate the vagus nerve by the outer ear and combine this with sounds. So, after almost more than 10 years, they try a similar method or theory even when the initial trials with MicroTransponder showed not much benefit. I personally doubt that the TU Delft device will be successful.

I wonder what is the crucial difference?

However, I will keep checking the progress here on Tinnitus Talk. Thanks for all your updates.

 

Having digested all of the information shared by @Christiaan, I'm mostly wondering why exactly Dr. De Ridder believes that the TU Delft device will offer a significantly different effect compared to Auricle. Ultimately, it targets the same nerve(s), albeit through different locations and minimally different applications (burst versus constant).

The NRC interview also includes a final paragraph in which Dr. De Ridder shares that he has tested the device himself, and that he is convinced that it targets the right area because he could feel his heart rate calm down. According to Dr. De Ridder this is a good sign because the heart is also closely connected to the vagus nerve.

Serdijn then mentions that he has also tried the device once, but that he can't really comment on it other than that he felt that his stress response to his tinnitus appeared weakened.