Department of Linguistics
Brain imaging of tinnitus and its remediation
a tinnitus participant
Project Leader: Dr Catherine McMahon
Other Researchers: Mr John Newall, Mr Christopher Sewell, Ms Emily Cale, Dr Blake Johnson and
Dr Graciela Tesan
We would like to invite you to participate in a research study on tinnitus. The study is being conducted by Dr Catherine McMahon, Mr John Newall, Mr Christopher Sewell, and Ms Emily Cale of the Department of Linguistics in conjunction with Dr Blake Johnson and Dr Graciela Tesan at the Macquarie Centre for Cognitive Science. Should you have any questions about any aspect of this experiment, please do not hesitate to contact Dr Graciela Tesan (email: graciela.tesan@mq.edu.au)
There are two aims to this experiment. Firstly we are trying to see whether we can identify differences in the brain between those who suffer from tinnitus and those who do not. Secondly we aim to look at what happens in the brain during and after treatment of tinnitus.
To measure brain activity we will be using magnetoencephalography (MEG). Our brain operates by sending tiny electrical signals. MEG scans involve lying under a machine which can detect the small magnetic field created by these electrical signals. MEG is completely non-harmful and non-invasive.
If you decide to participate in the study, you will be placed on one of two tinnitus treatment programs. One program involves the use of a portable device which plays specific music customised to your pattern of hearing loss (sound therapy), while the other involves psychology-based treatment. The sound therapy program involves using the device daily as recommended by your audiologist, typically for 1-2 hours. The sound is listened to through headphones, and the device can be used while doing other things. The device has been approved by the Therapeutic Goods Administration, is completely safe, and has been shown to be one of the most effective methods to treat tinnitus. The program lasts for six months. This program includes 6 appointments at the Macquarie University Audiology Clinic: a first assessment, a device fitting, and then follow up appointments at 2 weeks, 2 months, 4 months and 6 months. The treatment you will receive has not been modified in any way from usual.
During this period, the treatment will be presented to you free of charge. At the end of this period, some participants may wish to continue with the use of the treatment device. Unfortunately, after this initial period, the device cannot be provided for free. Participants will be given consultation on this matter with an audiologist. Purchase of the device, if requested, can be carried out at the Macquarie University Audiology Clinic. If you believe that you will find the removal of the treatment device distressing, then please do not participate in this study.
The psychology-based program is one that will use a Cognitive Behavioural Therapy (CBT) approach. Participants will attend one assessment session and eight therapy sessions of about one hour each once per week, at the Macquarie University Emotional Health Clinic. This style of therapy involves developing skills with a provisional psychologist during sessions, and then practicing those skills between sessions. Skills that will be developed in the program include reducing negative thoughts, modifying attention, achieving acceptance, and relaxing effectively. CBT is the most widely supported psychological treatment approach, and it has proved to be very successful at reducing the distress that tinnitus sufferers experience. Again, this treatment is provided free of charge, and does not differ from usual psychological treatment.
As part of this experiment, you will be asked to undergo an MEG scan before treatment begins, and also after 5 weeks, 10 weeks, 20 weeks and 30 weeks of beginning the treatment. These will take place at the Macquarie Brain Research Lab, located at 299 Lane Cove Rd. These are separate to your tinnitus treatment sessions mentioned above. Participants will be paid 20 dollars an hour for each of these sessions. These take approximately 2 hours each.
If you decide to participate in this study, information will be collected about your level of hearing and your tinnitus.
An audiogram will be conducted to measure your level of hearing loss. This involves listening to tones and responding to the audiologist when you can hear the tone. A professional audiologist will also conduct further examinations, including an otoscopy (examining the outer and middle ear by sight), a tympanometry and otoacoustic emission tests (used to determine ear function by recording the ear’s response to a sound). These measures are part of routine audiological check-ups. There is a possibility that these measures could detect an unknown medical problem. If you do not wish to be informed in the case of a medical problem, then please do not participate in this study.
Questionnaires will be given to you to fill out, measuring the effect of tinnitus on your life, your disposition and other factors such as your sleep. Questionnaires assessing your levels of anxiety and depression will also be given to you to fill out. In this study we are interested in both individuals who suffer from depression and anxiety, and those who do not. Answers to these questionnaires will be treated with confidentiality. If you do not wish to answer these questions, then please do not participate in this study.
When you receive an MEG scan, you will then be asked to remove any magnetic material from your clothing or your person. If you have magnetic material permanently fixed to your body (eg. dental work, a cardiac pacemaker, a cochlear implant, metal rods, plates or screws) then please do not volunteer for this study.
During the scan, we will tape five small coils to a cap on your head. We will use a digital pen to measure the location of these coils with respect to your head. Once you are inside the shielded room you will lie down on a bed. We will slide the bed so that your head rests in the helmet. You will be given foam tips to place in your ears which are connected to a set of headphones. This will allow you to listen to our instructions and the auditory input. Once you are comfortable, the researcher will leave the room and close the door.
There are two parts to the experiment. In the first part, we record five minutes of normal brain activity. In the second part, we will record the brains response to different tones. Pitches will be played into each ear and the brains activity will be recorded. Participants will be asked to keep their eyes open and to remain as still as possible. Other than this, no response during the experiment is required.
There are no known or foreseeable risks or side effects associated with MEG recording. However, you do need to lie very still during the measurement since movements interfere with the data. The shielded room is quiet and the lights are turned down low. If you think being in a small space will make you uncomfortable then please do not participate in this study. While in the MEG room, you will be able to hear us through headphones and communicate via a microphone. There is also a camera inside the room that allows us to see you – no recordings will be done through this camera. If you feel uncomfortable at any time during the experiment then simply contact the researcher and the experiment will be stopped.
The aim of this study is to investigate cortical activity in individuals with tinnitus. However there is a small chance that we may detect an unknown medical problem. This is not the purpose of the study. In the unlikely event that we do find a problem then we will contact you. If you would not like to be contacted in the event of an unknown medical problem then please do not participate in this study.
Participation in this study is voluntary. You are free to withdraw from this experiment at any time without having to give a reason and without consequence. Withdrawing from this research once begun, or declining to participate will not affect your relationship with your current audiologist, the Macquarie University Audiology Clinic, or with the company providing the device in any way. Only the researchers mentioned above will have access to the data. Any information or personal details gathered in the course of the study will remain confidential. No individuals will be identified in any publication of the results. Data will be securely stored for seven years. Information regarding the outcome of the study will be mailed to you upon completion of the research. Participation in this experiment involves being placed on the tinnitus treatment program, which includes 6 appointments at the Macquarie University Audiology Clinic for the sound therapy program, or nine appointments with a clinical psychologist at the Macquarie University Emotional Health Clinic for the CBT program, as well as undergoing 5 MEG scans at different times. If you believe in advance that you will not be available or will not be willing to dedicate this time then we kindly ask you not to participate in this research.
This study is funded by the Hearing Cooperative Research Centre.