Clinical Trial for
Acute (New Onset) Tinnitus

Overview

Previous studies have shown that applying a weak electrical stimulation to the scalp can lead to a small reduction in the loudness and impact of tinnitus for some people who have had tinnitus for many months or years already. But, electrical stimulation has never been tested in people who have only recently developed their tinnitus.
Our aim is to explore whether electrical stimulation and individual-tailored sounds may be more effective in quieting tinnitus when given early in the course of tinnitus, compared to later on.​

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What will I do?

The study involves a total of ten visits, spaced over around a month, to the study centre in Newcastle University Medical School, Newcastle upon Tyne, UK. The visits will involve:​

• Visit 1:

  • Discussion of the study, plus the signing of a consent form;

  • A hearing test (pure tone audiogram). In this, you are played quiet beep sounds at different frequencies (pitches) through headphones, and have to indicate which ones you can hear;

• Visits 1 and 10:​

  • Completion of standard questionnaires about tinnitus and its effect on you, about general mood and wellbeing;

  • A computerized task to establish what your tinnitus sounds like;

  • Further computerized tasks in which you will be asked to rate the loudness of sounds at various levels from just audible to (almost) uncomfortably loud;

• Visits 2-9:

  • An electrical stimulation session where a pair of electrode pads are placed on certain areas of your head (as pictured on top of this webpage);

• Visits 1, 2, 9, and 10:

  • An EEG (electroencephalography) test where we will measure your brain activity before and after the treatment. For the EEG recording, a fabric cap is placed over your head, and a number of spots of gel placed in this to help the electrodes pick up your brain activity.

 

You will be randomly assigned to receive either entirely ‘active’ electrical and sound stimulation (meaning they are applied in the way most likely to suppress your tinnitus), or entirely ‘placebo’.

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Who can take part in this study?

• You must experience tinnitus (persistent sound heard in one or both ears that is not coming from an external sound source or actual sounds being generated inside your body such as turbulent blood flow), which has persisted for at least 3 days, and began within the last 8 weeks. You do not need to be aware of the tinnitus all the time, but it must be persistent in the sense that you can always hear it if you listen out for it, and there is not enough other sound around to mask it;

• Aged 18 or over;

• Have the ability to make and communicate an informed choice about whether to take part in the study;

• Have the ability to sit still and comfortably in a comfortable chair for around 1 hour at a time.

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What would I gain by taking part in the study?

By taking part, you would be helping to better understand tinnitus in a way that might lead to improved treatments. Some volunteers find it an interesting experience to take part in this type of research. However, as this is a new treatment avenue, this study is unlikely to cure your tinnitus, and it is uncertain whether it will make any significant or lasting reduction in the loudness or other symptoms of your tinnitus. ​

The sound intervention used in the study can be made available for your ongoing and indefinite use if you perceive a benefit from it, and can be listened to via most computers, smartphones or MP3 players. If you receive the placebo sound intervention then you will be given the active version to use in future, should you wish to. There is presently no mechanism by which we can continue to provide the electrical stimulation after the end of the study. 

The procedures used are generally safe. We also will reimburse any reasonable travel expenses incurred for each visit, and a participation fee as a thank you for your time and effort.

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Where does the study take place?

The study takes place in the Clinical Sensory Cognition Laboratory at Newcastle University Medical School, which is on Framlington Place, Newcastle upon Tyne, NE2 4HH.

The meeting point is the Medical School Main Reception, at the Medical School entrance.​​​