Deep Brain Stimulation (DBS) for Tinnitus

#122
I thought I'd do a brief recap on the state of deep brain stimulation trials as of June 2022:

There are two trials going on in Europe, one from Maastricht University in the Netherlands, and one from the University Hospital in Grenoble, France. No data is available yet, and it is unclear to me what phase these trials are on.

There has also been a Phase 1 trial in the U.S., completed in 2019. Here's the article that describes the trial. Although the procedure is extremely invasive, it appeared to be relatively safe, with no adverse events reported (except for one patient, but that was apparently unrelated to the procedure), and reasonably effective. I haven't found any more information regarding a phase II of this study so I am assuming it is in limbo, but I'll reach out to the investigators to learn more.

Whether DBS simply treats the distress caused by tinnitus or actually lowers tinnitus volume is unclear. I've read conflicting anecdotal reports in this form (one was a secondhand account from a participant of the Maastricht trial, and the other was a firsthand report from a participant of the U.S. study).

Here's something I've been thinking: I remember that there was a paper on non-invasive deep brain stimulation that made some big waves in 2017. It seems the technology is promising but needs some fine-tuning (I found a 2020 paper that suggests improvements on the tech). I find this approach fascinating, but it seems so far no one has tried to use it to treat tinnitus. I wonder why. I think I know a researcher I can ask this question to; I'll post their response here if I hear back.
 
#123
Tasty said:
Hey, Ela. Did they respond to your email?

Anyways, I haven't followed Tinnitus Talk long enough; do you have any expectations when DBS will be available for tinnitus?
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The trial at the Maastricht University doesn't accept patients outside of the Netherlands. The trial at Grenoble doesn't accept patients outside of France.

I really don't know when it would be available. They are only running trials at the moment.
addot said:
I thought I'd do a brief recap on the state of deep brain stimulation trials as of June 2022:

There are two trials going on in Europe, one from Maastricht University in the Netherlands, and one from the University Hospital in Grenoble, France. No data is available yet, and it is unclear to me what phase these trials are on.

There has also been a Phase 1 trial in the U.S., completed in 2019. Here's the article that describes the trial. Although the procedure is extremely invasive, it appeared to be relatively safe, with no adverse events reported (except for one patient, but that was apparently unrelated to the procedure), and reasonably effective. I haven't found any more information regarding a phase II of this study so I am assuming it is in limbo, but I'll reach out to the investigators to learn more.

Whether DBS simply treats the distress caused by tinnitus or actually lowers tinnitus volume is unclear. I've read conflicting anecdotal reports in this form (one was a secondhand account from a participant of the Maastricht trial, and the other was a firsthand report from a participant of the U.S. study).

Here's something I've been thinking: I remember that there was a paper on non-invasive deep brain stimulation that made some big waves in 2017. It seems the technology is promising but needs some fine-tuning (I found a 2020 paper that suggests improvements on the tech). I find this approach fascinating, but it seems so far no one has tried to use it to treat tinnitus. I wonder why. I think I know a researcher I can ask this question to; I'll post their response here if I hear back.
Click to expand...
The data I had from the Maastricht University trial was from an earlier point of the trial, I have no further results or information on how the trial progressed.

The trial in France says on their page that it is still recruiting, so did the trial start or not?

The person participating in the U.S. trial never said if his tinnitus went away. Actually at one point he says he doesn't have data about the other participants, if their tinnitus went away, which makes me think that his tinnitus did go away!

They are recruiting again this summer in the U.S., I saw the same doctor in the new trial.

New Tinnitus Research Focused on Neural Networks Shows Promise for Precision Treatment

I assume you have to be in the U.S. for this one?

Also the articles you have posted, they don't have any clear conclusions in terms of did they help patients with tinnitus or not?

And there is this big thing with noise sensitivity. You can't have noise sensitivity but you can still have reactivity to noise when you have tinnitus. Most people with tinnitus wear hearing protection in noisy situations so where can the line be drawn, who can qualify for these trials in terms of how your tinnitus would react to noises? Because some or most of this reactivity is related to central gain and the maladaptative connections created in the brain due to tinnitus (dysfunctional auditory nerve), which I'm thinking the DBS surgery will correct? At least to a degree where you feel a great reduction in your tinnitus.

We need more answers.
 
#124
Ela Stefan said:
The person participating in the U.S. trial never said if his tinnitus went away. Actually at one point he says he doesn't have data about the other participants, if their tinnitus went away, which makes me think that his tinnitus did go away!
Click to expand...
He did say this:
Roadglide said:
It didn't stop the noise in my head totally it stops the reaction to the noise. It definitely has changed my life for the better .I went from not wanting to live back to living a normal life.
Click to expand...
If you mean that he never said if his tinnitus went away eventually, years after the treatment, then yeah, you're right, he hasn't (and he's no longer active here).
Ela Stefan said:
They are recruiting again this summer in the U.S., I saw the same doctor in the new trial.

New Tinnitus Research Focused on Neural Networks Shows Promise for Precision Treatment

I assume you have to be in the U.S. for this one?
Click to expand...
Great find! Thanks so much for sharing. So it seems they are trying to really zero in on precisely which regions of the brain are involved in tinnitus for each patient. It seems like the right call, hopefully it leads to more effective DBS treatments. And yeah, I'd assume you would have to be in the U.S. for the trial.
Ela Stefan said:
Also the articles you have posted, they don't have any clear conclusions in terms of did they help patients with tinnitus or not?
Click to expand...
Kind of, but let's dig a little deeper into that article from the U.S trial because the results are interesting.

60% of participants from the U.S. trial showed "clinically significant improvement". How did they measure this, and what does it mean? For their primary outcome, they used the Tinnitus Functional Index (TFI), which is basically a survey in which you describe how tinnitus impacts your daily life. They also asked participants to describe the loudness of their tinnitus on a scale of 0 to 10 before and after the treatment; this was used as one of their secondary outcomes. For both of these outcomes though, the effect sizes were huge. The mean decrease in TFI scores was 23.3, but that ranged from a participant who only had a 2.4 decrease to a participant that had a whopping 70.4 point decrease (their TFI went from 75.6 to 5.2. Imagine that). Nevertheless, of the five participants, three (60%) had a TFI decrease of over 13 points, which is how they define clinically significant improvement. Tinnitus loudness reduction followed a similar pattern: the mean reduction was 2.5, but that ranged from a participant reporting a 7.8 point improvement to a participant reporting 0 change (most other participants reported an improvement of around 1.5 points. Remember these points are on a scale of 0-10, not in dB).

To summarize, they had a super responder for whom DBS basically cured their tinnitus. There were other two participants who improved, but to a lesser degree, and two participants who didn't. Worth noting that this was a Phase 1 study, so the real focus was on safety rather than effectiveness. It seems that they are now trying to figure out why some people responded so well and why some didn't. Which is great, but sadly it means that a phase II of the study really is in limbo (if it even happens at all).
 
#127
Tasty said:
ClinicalTrials.gov: Deep Brain Stimulation for Tinnitus

Does anyone have more information on this? There are no clinical phases (1, 2, 3, 4 etc..) displayed but it got published shortly after conclusion of Phase 1 (LC) Caudate Stimulation that concluded in 2019.
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Did you find any results for the first clinical trial? I don't see it on the link you posted!

What do you understand by chronic and stable tinnitus? Does this mean fluctuations in tinnitus due to noise is an exclusion criterion?
 
#128
Ela Stefan said:
Did you find any results for the first clinical trial? I don't see it on the link you posted!

What do you understand by chronic and stable tinnitus? Does this mean fluctuations in tinnitus due to noise is an exclusion criterion?
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I understand tinnitus being chronic if you have had it for more than 3-6+ months. But I honestly can't answer what "stable" means because mine fluctuates a lot so I'm not quite sure about this.

I also found Dr. Dirk De Ridder's Tinnitus Talk Podcast very insightful.

Tinnitus, Ingrained in the Brain? - Prof. Dirk De Ridder

Lots and lots of idiots (especially GPs) tell you tinnitus is Ingrained or burnt in your brain lol, what obviously makes no sense if DBS works, the brain just seems to be in a waggy state, especially the thalamus where information is filtered out and yeah, I have to agree on the concept of thalamocortical dysrhythmia, from that perspective all makes sense and especially the mechanisms of DBS.

Surgical Neuromodulation of Tinnitus: A Review of Current Therapies and Future Applications
Multiple imaging studies are employed to understand the pathophysiology of tinnitus. Abnormal regions and altered connectivity implicated in tinnitus include auditory pathway and limbic structures. Neuromodulation attempts to correct this hyperexcitable state by disrupting these aberrant oscillations and returning activity to baseline. Applied treatment modalities include transcranial magnetic stimulation, epidural/intradural electrode stimulation, and DBS. More recently, modulation of autonomic pathways through vagus nerve stimulation and paired auditory sounds has demonstrated tinnitus improvement via plasticity changes.

DBS shows much promise as a therapeutic option for tinnitus. Stimulation of the auditory pathway, particularly the medial geniculate body, could counteract thalamocortical dysrhythmias and reduce gamma activity implicated in the tinnitus percept. Stimulation of the limbic pathway could decrease attention to and perception of tinnitus. Additional studies, focusing on the involvement of thalamic and limbic structures in the pathophysiology of tinnitus, are needed to support the use of DBS.
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#129
I contacted the team from Grenoble.

They said it takes much more time than expected, for now they have operated only 1 patient.

I may take the risk to be a guinea pig (if my very recent hyperacusis increase subsides..)

I need to contact an ENT from their hospital before setting an appointment in September with the neurologist in charge of the project (as an anecdote, it appears to be the same guy who first operated Michael Schumacher after his ski accident, which tends to scare me even if after some research he apparently did a good job on him but he was way too damaged).
 
#130
lusiol said:
I contacted the team from Grenoble.

They said it takes much more time than expected, for now they have operated only 1 patient.

I may take the risk to be a guinea pig (if my very recent hyperacusis increase subsides..)

I need to contact an ENT from their hospital before setting an appointment in September with the neurologist in charge of the project (as an anecdote, it appears to be the same guy who first operated Michael Schumacher after his ski accident, which tends to scare me even if after some research he apparently did a good job on him but he was way too damaged).
Click to expand...
God, so they gave no timeframe when the trial will finish? As I understand it, they don't take this treatment off label until they finish the trial and see the results? I'm not from France, so I can't get in. Also, my tinnitus is reactive to more sound. I keep seeing them state that they only accept stable tinnitus for the trials?

Mine is sort of sensory tinnitus, more so related to the brainstem (or starting from there) than the ear. So logically it would be reactive. In my mind the voltage of the DBS implant will regulate impulses and the reactivity would go away.
 
#131
Ela Stefan said:
God, so they gave no timeframe when the trial will finish? As I understand it, they don't take this treatment off label until they finish the trial and see the results? I'm not from France, so I can't get in. Also, my tinnitus is reactive to more sound. I keep seeing them state that they only accept stable tinnitus for the trials?

Mine is sort of sensory tinnitus, more so related to the brainstem (or starting from there) than the ear. So logically it would be reactive. In my mind the voltage of the DBS implant will regulate impulses and the reactivity would go away.
Click to expand...
Yeah it's just an evaluation, they are sadly far from "off label" treatment for now.

They don't mention reactive tinnitus as a criteria:

Inclusion Criteria:
  • Between 18 and 75 years old,
  • Uni or bilateral permanent non-pulsatile tinnitus, without associated vestibular pathology, with or without hearing loss,
  • Severe tinnitus resistant to treatment failure,
  • Tinnitus intensity on the Visual Analog Scale (VAS) ≥ 7,
  • Presenting a quality of life score on the Tinnitus Handicap Inventory (THI) questionnaire> 76 (= grade 5),
  • Social security affiliates or beneficiaries of such a scheme
  • Informed and written consent signed by the patient.

Exclusion Criteria:
  • Vestibular dysfunction (balance disorder),
  • Epilepsy,
  • Intercurrent serious pathology,
  • Brain tumor,
  • Contraindication to surgery or anesthesia,
  • History of cerebral infection with herpesvirus,
  • With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT) scan,
  • Under anticoagulants and antiaggregants (Anti vitamin K, low molecular weight heparin, aspirin and derivatives, clopidogrel antiplatelet agents and assimilated, new oral anticoagulants (NACO)) for which a therapeutic window can not be opened within 3 months before and after the surgery,
  • Included in another therapeutic protocol,
  • Progressive dementia or psychiatric illness,
  • Presenting a suicidal risk deemed important for less than 3 months (Montgomery and Asberg depression scale (MADRS): suicidality item (item 10) score> 2),
  • Enforced hospitalisation,
  • Pregnant, parturient or breastfeeding, lack of contraception in patients with the capacity to procreate,
  • Subject to a legal protection measure,
  • Deprived of liberty by judicial or administrative decision,
  • Isolated patient without any contact in case of emergency.
 
#132
lusiol said:
Yeah it's just an evaluation, they are sadly far from "off label" treatment for now.

They don't mention reactive tinnitus as a criteria:

Inclusion Criteria:
  • Between 18 and 75 years old,
  • Uni or bilateral permanent non-pulsatile tinnitus, without associated vestibular pathology, with or without hearing loss,
  • Severe tinnitus resistant to treatment failure,
  • Tinnitus intensity on the Visual Analog Scale (VAS) ≥ 7,
  • Presenting a quality of life score on the Tinnitus Handicap Inventory (THI) questionnaire> 76 (= grade 5),
  • Social security affiliates or beneficiaries of such a scheme
  • Informed and written consent signed by the patient.

Exclusion Criteria:
  • Vestibular dysfunction (balance disorder),
  • Epilepsy,
  • Intercurrent serious pathology,
  • Brain tumor,
  • Contraindication to surgery or anesthesia,
  • History of cerebral infection with herpesvirus,
  • With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT) scan,
  • Under anticoagulants and antiaggregants (Anti vitamin K, low molecular weight heparin, aspirin and derivatives, clopidogrel antiplatelet agents and assimilated, new oral anticoagulants (NACO)) for which a therapeutic window can not be opened within 3 months before and after the surgery,
  • Included in another therapeutic protocol,
  • Progressive dementia or psychiatric illness,
  • Presenting a suicidal risk deemed important for less than 3 months (Montgomery and Asberg depression scale (MADRS): suicidality item (item 10) score> 2),
  • Enforced hospitalisation,
  • Pregnant, parturient or breastfeeding, lack of contraception in patients with the capacity to procreate,
  • Subject to a legal protection measure,
  • Deprived of liberty by judicial or administrative decision,
  • Isolated patient without any contact in case of emergency.
Click to expand...
I really don't understand why they go so slowly...
 
#133
Ela Stefan said:
I really don't understand why they go so slowly...
Click to expand...
Well, I'm more confident on the trial in Maastricht and in the US by Dr. Cheung (Phase 2).

If we're lucky, we'll have some decent results by end/beginning of next year in PubMed. For universal use, I'd expect at least 5-10 years, sadly. I mean, I don't know, it's not something I can go for and ask lol... (yet).
 
#134
Tasty said:
Well, I'm more confident on the trial in Maastricht and in the US by Dr. Cheung (Phase 2).

If we're lucky, we'll have some decent results by end/beginning of next year in PubMed. For universal use, I'd expect at least 5-10 years, sadly. I mean, I don't know, it's not something I can go for and ask lol... (yet).
Click to expand...
Is Dr. Cheung doing a Phase 2? I tried to research that before and couldn't find it.
 
#135
#136
I actually met Dr. Cheung recently to get his advice on my particular tinnitus symptoms. I didn't realize at the time that this is the research that he's involved with. He didn't mention his research when I met him. I want a follow-up appointment, but he's booked out for months.
 
#137
Joe Cuber said:
I actually met Dr. Cheung recently to get his advice on my particular tinnitus symptoms. I didn't realize at the time that this is the research that he's involved with. He didn't mention his research when I met him. I want a follow-up appointment, but he's booked out for months.
Click to expand...
If you have a chance to meet him again, please ask him about this treatment. I would honestly consider this but got no timeline whatsoever. I would really want to know his plans with it and his timeline.
 
#138
Tasty said:
If you have a chance to meet him again, please ask him about this treatment. I would honestly consider this but got no timeline whatsoever. I would really want to know his plans with it and his timeline.
Click to expand...
I'll see what I can find out. I'll be booking an appointment soon, and his staff is who I speak with when i book, but I'll see if there's a way I can send a message along to him.
 
#139
Tasty said:
If you have a chance to meet him again, please ask him about this treatment. I would honestly consider this but got no timeline whatsoever. I would really want to know his plans with it and his timeline.
Click to expand...
I don't think you can get in the trials unless you are from the United States.
 
#140
Joe Cuber said:
I'll see what I can find out. I'll be booking an appointment soon, and his staff is who I speak with when i book, but I'll see if there's a way I can send a message along to him.
Click to expand...
That would be awesome. I just hope he can give some information about when it will be available for severe tinnitus, and what are his expectations. I would, like I said before go for it right away if I knew it can eliminate tinnitus, and surprisingly it can :)

It's a shame that it's not available and so many good people are still suffering. It ccould make such a difference, I think, if someone is having suicidal thoughts (for example). He'd rather go for DBS and silence instead of despair...
 
#142
lusiol said:
Can I ask why? DBS was invented in Grenoble so I would tend to think they have more experience with this stuff, no?

I don't have your science knowledge though.
Click to expand...
Grenoble just had their first DBS clinical trial for tinnitus, no? They have done DBS for tinnitus in the United States since 2017.
 
#143
Ela Stefan said:
Grenoble just had their first DBS clinical trial for tinnitus, no? They have done DBS for tinnitus in the United States since 2017.
Click to expand...
lusiol said:
Can I ask why? DBS was invented in Grenoble so I would tend to think they have more experience with this stuff, no?

I don't have your science knowledge though.
Click to expand...
They also investigated other settings and stimulation patterns, e.g., one trial targets the medial geniculate body whilst the other targets the caudate nucleus. And as mentioned, they already completed Phase 1 and enroll for Phase 2 soon so they are major steps ahead and they are basing their work on precise neuroimaging e.g., the UCSF and Maastricht.
 
#145
#148
Christiaan said:
Hi everyone, it took a while but I finally came into contact with someone who was involved in the DBS study at the Academic Medical Center (AMC) in Amsterdam. Dr. Dijkstra is one of the leading specialists of this particular DBS trial (concerning Rianne Kok) and she was so kind as to provide me the case study paper that might give some insights for some of you here on Tinnitus Talk.

One thing worth noting in my correspondence with Dr. Dijkstra is that AMC is planning to conduct more DBS research in the future. That's at least some good news for those who are considering this kind of treatment.

Anyway, here's an evaluation + PDF document of the case study.

Effective deep brain stimulation of intractable tinnitus: A case study (Dijkstra et al., 2018)

''In this patient with severe intractable tinnitus, one year of vALIC-DBS resulted in major improvement of the tinnitus. Even though the tinnitus was still present, DBS enabled her to cope with the sound and fully direct her attention to normal daily life, which also greatly improved her mood. This suggests that vALIC-DBS primarily improved tinnitus-related distress and not merely depression, which is supported by the observation that temporarily DBS-discontinuation caused a primary relapse of tinnitus symptoms. Interestingly, improvement was first achieved with 4V-stimulation, which became more durable at 4.5V and was sustainable only at 5V, suggesting a dose-dependent stimulation effect.''

''As of yet, beneficial effects of DBS for tinnitus have only been reported as coincidental finding. For example, tinnitus was retrospectively assessed in 443 patients receiving subthalamic nucleus DBS for movement disorders, of which 61 patients reported having experienced tinnitus before DBS [9]. During DBS, their mean THI score significantly decreased compared to pre-surgically (...) Accordingly, a pilot study of area LC-DBS is currently performed in ten tinnitus patients (trial NCT01988688). It has been proposed that tinnitus is caused by altered sensory input, such as auditory deprivation,which induces functional changes in a network of auditory and non-auditory structures.''

''Nonauditory structures, such as the basal ganglia, have been proposed being involved in the gating and selecting of the tinnitus sound. Accordingly, the NAc shows structural and functional abnormalities in tinnitus patients compared to healthy controls, such as significant grey-matter decrease and tinnitus-evoked hyperactivity. We have previously demonstrated that vALIC-DBS for OCD is able to normalize NAc activity and excessive connectivity from the NAc. Based on these findings, we hypothesize that vALIC DBS improves tinnitus symptoms by restoring basal ganglia function, enabling healthy affective gating of the tinnitus percept. To the best of our knowledge, the current case study is the first to report effectiveness of vALIC-DBS for severe intractable tinnitus, casting hope for this intervention in other patients with intractable tinnitus.''
Click to expand...
How can you get in touch with the Academic Medical Center (AMC) in Amsterdam, Dr. Dijkstra?
 

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