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

I've just discovered that Dr. De Ridder has collaborated with Delft University of Technology on developing a bi-modal stimulation device that is quite similar to Shore's Auricle.

There are plans to start clinical trials with this device, but so far I can't find any information about when it might take place.

Here's a summary of the research paper:

Abstract

Approximately 15-20% of the world population is affected by tinnitus, a hearing condition associated with phantom sound perception. A large number of sufferers experience a severe level of tinnitus and they are not able to conduct a normal life because they develop insomnia, depression, and distress.

However, currently there are no treatments that have demonstrated to be effective in modulating tinnitus or suppressing its related annoyance from a long-term perspective. What is known is that the patients exhibit abnormal electrical activity in multiple areas of the auditory and the central nervous systems. This is the reason why the focus of the scientists has shifted to multi-modal stimulation: multiple stimulations of equal or different nature (e.g. double electrical stimulation or acoustic-electrical stimulation) are applied at the same time in the attempt to induce neuroplasticity and restore the normal electrical activity in the targeted areas. Multi-modal stimulation has brought significant improvements both in terms of tinnitus intensity and distress, but the studies conducted are too little to derive conclusions.

The challenge of this work is to design a portable multi-modal stimulator that is able to provide bilateral acoustic and electrical stimulation simultaneously. The device works at the same time as an audio player and a transcutaneous electrical nerve stimulator, with the purpose of contemporaneously stimulating the auditory cortex and the autonomic nervous system or the dorsal cochlear nucleus through the vagal nerve or the C2 nerve, respectively. Bi-modal stimulation is based on the random presentation of pure tones matched to the tinnitus frequency pitch combined with two possible electrical stimulation wave forms: a novel one characterized by the superposition of a low-frequency noise on a DC component ("noise + DC" stimulation) and the second one is burst stimulation. Both the electrical stimulations are current-driven and largely customizable due to the wide programmability of the stimulation parameters. The analog design is realized in such a way that two identical output currents are delivered to the tissue, allowing for bilateral stimulation. The low power consumption and the small dimensions and weight of the device will permit the tinnitus patient to use it for several hours per day while performing his daily life without impairments.

 

Good find @Christiaan! Can't you just ask him about it? Sign me up!

 

Yep, I'm planning to ask him about it. Next appointment on 11th of April.

 

I and a friend of mine attended years ago a study which also stimulated the vagus nerve through the ear. The device was called NEMOS by Cerbomed and the study was done at the Regensburg clinic.

The company actually stopped selling it. There was no effect on tinnitus.

Now it looks like they just add sound(s) to this? I doubt this will be effective honestly.

 

Based on preclinical animal models, there is reason to belief that pairing sound with electrical stimulation induce greater effect on tinnitus percept and promotes neuroplasticity than using electrical intervention alone. See: Engineer, N. D. et al. Reversing pathological neural activity using targeted plasticity Nature 470, 101–4 (2011).

It's also the question of finding the optimal stimulation parameters. For example, recent animal research demonstrated that moderate intensity of VNS (0.4 and 0.8 mA) drive greater plasticity compared to VNS at higher intensities (1.2 and 1.6 mA). More info: Borland, M. et al. Cortical map plasticity as a function of vagus nerve stimulation intensity. Brain Stimul. 9, 117–23 (2016).

There's also TT'er @Archer in the MicroTransponder thread, who reported that VNS + sound intervention helped diminish his tinnitus: https://www.tinnitustalk.com/posts/545124/

 

@Christiaan, do you know if they will conduct trials here in the Netherlands?

 

I've asked a foundation (Stichting Brain Innovations) via e-mail a few days ago about this matter. They've responded that they'll get back to me as soon as possible. The foundation is closely connected to the Delft University of Technology research.

 

Thanks for your response. I’d be happy to know if there is a trial or compassionate use of this soon. Could you please let us know when you know more.

Thanks

 

Sure thing, @Pharz.

Have you also checked the NeuroVR thread? You can sign up to their newsletter for future trials in the Netherlands.

 

Ok, so there's good news for people in Europe. I've just received an email from a Professor who is connected to the TU Delft study. Professor Serdijn mentions in this email that Brai3n clinic will start a trial with the bimodal device for tinnitus. He adds that there's no clear planning when this study will start, but it's best advised to contact Dr. De Ridder about this particular matter.
--------------------------------------------------------------------
Beste heer Van Romondt, beste Christiaan,

Het antwoord hierop is een volmondig ‘ja’. Het proefonderzoek zal plaatsvinden in de BRAI3N-kliniek van Prof.Dr. Dirk de Ridder. Zijn email-adres staat in het Cc-veld van deze email. Hij kan u het beste informeren over wanneer de eerste onderzoeken kunnen plaatsvinden.

Met vriendelijke groet,
Wouter Serdijn

 

Anybody knows when the clinical trial will start and how to take part in it?

 

Dr. De Ridder has told me that he's currently working on a redesign of the TU Delft device and that he hopes that the device is ready sometime in May for a future trial. I guess we just have to contact him around that time to know more when the trial will take place. At least one thing we know for sure is that the trial will take place at the Brai3n clinic.

 

Any news? Do you guys really think this can work?

 

I was trying to set up an online appointment with Dirk de Ridder and ask about it but he is only available for that in September. It seems a black box for the moment.

 

September isn't so far away. Did you book it?

 

I emailed Dr. De Ridder a few days ago. I'm still waiting for an answer.

 

I’m trying to arrange a 1-1 meeting with him in August since I will be in the Netherlands for 2 weeks that time.

 

Hi Christiaan,

Did you get any reply in the meantime?

 

I confirmed with Brai3n that this study is currently on hold. They didn’t tell me for how long.

 

On hold as in they need more time, or on hold as in IT'S OVER/DON'T HOLD YOUR BREATH .

Honestly all we need to know is if this method at least works. Once we know that, then I could rest easy waiting, but Dr. Shore hasn't even given us results and so we are not sure if this method works at all.

 

Maybe somebody should ask this question from Dr. De Ridder or Jan Ost from Brai3n.

I can't imagine that this device / approach would do anything for tinnitus.

 

I found this study on Google:

Vagus nerve stimulation paired with tones for tinnitus suppression: Effects on voice and hearing

What do you think?

 

I think it's pretty valid. The vagus nerve feeds into the thalamus and auditory pathways so in theory it should work in at least reducing the tinnitus.

Sure, Deep Brain Stimulation is another thing but they share some similarities, e.g., the thalamus. In DBS you place them to combat thalamic dysrhythmias. In VNS you stimulate the nerve that feeds into the thalamus, so in theory, it "could" work.

 

Isn't there already a stimulation device for vagus nerve on the market?

 

Yes I think so, just not for tinnitus unfortunately, but they conducted a few studies about it as far as I know.

But honestly, if I had the choic,e I'd go for DBS instead of VNS.

 

This one is vagus nerve stimulation device, been available on the market for tinnitus for years already. Didn’t work for me, I don’t believe it helps better than placebo:

https://www.parasym.co/

 

I know you're speaking hypothetically, but do you (or anyone else) know if there are any progress in bringing DBS to market? Any clinical trials, companies that focus on it? I'm not caught up at all on that side of the research.

 

You can find that information on the DBS surgery thread. There are two trials going on as of now in Europe, one in the United States. Two of them are still recruiting. For the European trial, you would have to be in France.

They are hit and miss at this moment, they still try to figure out where the better spots on the auditory nerve pathways are where they can implant those electrodes.

We still don't even have official partial results.

 

Yep, that's the question, what is a real timeline for DBS. I'm not quite sure about it either.

I want to set myself a timeline (at least I've tried it then/instead of doing nothing for the tinnitus)

 

No, still no answer. I guess he's on vacation. I'll send him another reminder in a few weeks.