Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation StudY (WHITBY)

[Nick47]

From Nottingham University:

Tinnitus - the awareness of sound without any outside source - affects around 15% of people and can cause anxiety and depression. Treatment options are limited and do not address tinnitus directly (e.g., reduce its loudness). To do that, we must change brain activity causing tinnitus. Low-dose electrical stimulation, using a technique called transcranial Direct Current Stimulation (tDCS), is a promising approach. The technique is safe and easy to administer. Several small studies have tested tDCS for tinnitus showing some benefits.

To assess whether these benefits will generalise to other patients, we need to conduct a randomised controlled trial - a large, rigorously controlled experiment based on prior agreed procedures. Clinical trials are expensive and time-consuming to run and thus require meticulous pilot work to establish the most effective treatment regimens and the most sensitive measures of treatment outcome. The current study aims to provide such pilot information for a clinical trial of tDCS treatment of tinnitus. Using a total of 40 patients, we will establish how to best to administer tDCS and measure resulting changes in tinnitus perception and associated brain activity.

The current study is a crucial first step towards determining whether or not tDCS can effectively treat tinnitus.

→ Working Towards Better Healthcare Interventions for Tinnitus: a Brain Stimulation StudY (WHITBY)

 

[withintention]

It's great to see another clinical trial starting!

However, I'm curious about one of the inclusion criteria:

"Suffering from subjective idiopathic tinnitus."

Does this mean that if you know the cause of your tinnitus, such as noise exposure, you're ineligible?

 

[Cmspgran]

Subjective tinnitus refers to nearly all cases except for the rare 2% in which a surgeon can actually hear the tinnitus or when it can potentially be treated with surgery. Noise-induced tinnitus almost always falls into the category of subjective tinnitus. When you visit an ENT and they can't identify a physical cause—which happens about 99% of the time—they'll typically note it as "idiopathic subjective tinnitus." The usual recommendations are sound therapy and relaxation techniques. After that, it's on to the next patient for £200. You get the picture.

 

[Nick47]

"Suffering from subjective idiopathic tinnitus."

@withintention, I didn't see that.

 

[IYIiKe]

Some of these studies have unrealistic parameters, though it's understandable to a degree. For example, excluding anyone with depression or anxiety is unrealistic, as severe sufferers are more prone to these conditions simply because it's a difficult experience. Parameters like "idiopathic only" are also unhelpful, as they'll likely lead to NIHL sufferers misrepresenting their condition.

 

[Nick47]

ENT and they can't identify a physical cause—which happens about 99% of the time—they'll typically note it as "idiopathic subjective tinnitu

@Cmspgran, so if they identify hearing loss as the cause, is it still idiopathic?

 

[Cmspgran]

@Cmspgran, so if they identify hearing loss as the cause, is it still idiopathic?

I believe so, yes. I experience dips in my hearing, and when I went to see a private ENT at the start of this nightmare, he didn't seem interested in those dips. He sat in front of me and said, "So... you have idiopathic tinnitus; it's been worsened by an MRI, but it'll improve over time." He then mentioned he'd been involved in a trial related to magnetic fields and tinnitus relief—though I'm not entirely sure what he was going on about. He's one of the top ENTs in the country. This was before I saw Professor Bance.

As I understand it, anything not linked to a specific physical issue in the ear, though hearing loss is partly physical, is classified as idiopathic. They're mainly referring to non-operable issues or cases like pulsatile tinnitus.

 

[Nick47]

He then mentioned he'd been involved in a trial related to magnetic fields and tinnitus relief—though I'm not entirely sure what he was going on about.

@Cmspgran, I think it might be some kind of TMS-related thing. I'll apply for the study, but only if it doesn't involve a loud MRI. Naturally, the study doesn't mention that part.

 

[ColinUK]

I contacted the study organizer, and there is an optional MRI component. Some of the hearing tests reach 85 dB, which might be an issue for me, but I've applied to be part of the trial.

 

[Nick47]

I have emailed the study organizer.

 

[Joeseph Stope]

Why am I writing this? It's all part of "The Science of Everyday Experience."

Tinnitus may be much more connected to stress or emotions than we realize. Case in point: myself.

Last June, we received notice from our landlord, who plans to sell the house. It was a shock at first, but life goes on. Now, as the final moving date approaches, my tinnitus is at an all-time high.

Of course, the data is as inconclusive as ever. Is the spike due to the winter COVID-19 and flu shots I got? Exposure to loud motorcycle noise? The stress of house-hunting? Or maybe it's the subconscious emotions stirred up by leaving my familiar surroundings?

One thing feels certain to me: the tinnitus has come loudly to the forefront. Whatever the trigger, it's a real issue.

 

[Nick47]

contacted the study organizer, and there is an optional MRI component. Some of the hearing tests reach 85 dB, which might be an issue for me, but I've applied to be part of the trial.

@ColinUK, I contacted Bas Labree and received the same information. I had an MRI in 2022, so I can send them that if needed. I'm not too keen on those 85 dB hearing tests. Did you ask them if these tests are mandatory or if there's any flexibility?

We'll either be in the treatment group or the placebo group. There's £250 compensation for attending all sessions, so that's a plus.

 

[ColinUK]

Did you ask them if these tests are mandatory or if there's any flexibility?

@Nick47, I didn't ask, to be honest. For me, it depends on when the trial starts. I was informed it could be December, or it could be January. I'm not sure how feasible December will be, but if I manage to get in, I don't think I'll be able to tolerate 85 dBA. If that's an issue, I'll just see what they say.

At the end of the day, it's pretty obvious to me whether the tinnitus is going to get any quieter, with or without any hearing tests.

 

[Nick47]

I asked the researcher some questions about the protocol. This is what I was told:

You'll have read that there is an MRI component to the study, but this is very much optional (we're only doing this on 10 of the 40 participants). If you don't want to have one as part of the study, especially given your hyperacusis, that is absolutely fine. I'll double-check, but given the study protocol, ethical approval and data management plan in place, we likely won't be able to accept your clinical MRI as data for the study.

We're not planning to test otoacoustic emissions or ABRs, just a hearing test and a tinnitus loudness matching procedure. The other auditory stimuli presented are for the auditory evoked responses (seeing how your brain responds to sounds, as measured with EEG). Any sounds presented for the hearing test, tinnitus loudness matching or the auditory evoked responses should be well below 85 dB. All three are necessary for the study, but if at any stage you feel you're approaching the limit of your sound tolerance, we can stop.

We're not excluding participants based on hearing ability, so your hearing loss doesn't affect your eligibility.

At the end of the day, it's pretty obvious to me whether the tinnitus is going to get any quieter, with or without any hearing tests.

@ColinUK, yes, but this is a clinical trial focused on measuring changes in the brain. It is not a treatment, though it could potentially lead to one. Additionally, there is a 50% chance of being placed in the placebo group!

 

[StressedWeasel]

@Nick47, I didn't ask, to be honest. For me, it depends on when the trial starts. I was informed it could be December, or it could be January. I'm not sure how feasible December will be, but if I manage to get in, I don't think I'll be able to tolerate 85 dBA. If that's an issue, I'll just see what they say.

At the end of the day, it's pretty obvious to me whether the tinnitus is going to get any quieter, with or without any hearing tests.

Any news about this research? Did it start already or does it start in January?

 

[Nick47]

Any news about this research? Did it start already or does it start in January?

@StressedWeasel, December/January.