We invite you to participate because you have been diagnosed with elevated thyroid function due to the immune system being activated, so-called Graves’ disease.
To be able to take a second step towards answering the question “Can the immune system contribute to brain fatigue in Graves’ disease?” we need to recruit 310 people with Graves’ disease to be examined at diagnosis and after 15-18 months and 120 controllers. This study is based on a first step where we developed possible markers that the immune system is involved in the development of mental fatigue in Graves’ disease. We now need to see if this is true in another group of patients with Graves’ disease. We hope that the biomarkers can be tested further in a third step and then open up for new insights into the cause of mental fatigue.
CAN YOU JOIN?
To be able to participate in the study, you must:
- be between 18-72 years
- newly diagnosed with Graves’ disease (examination within 3 weeks after taking thyroid inhibitory medication)
Additional things that we must take into account are:
- the examination must be done before or within 3 weeks after starting with antithyroid medications
- there must be thyroid antibodies (so-called TRAK)
- the level of thyroid hormones must be outside the normal range
- that you have met the conditions to carry out the study protocol in a satisfactory manner
If this applies to you and you are interested in participating in the study, you can read on at your leisure.
WHAT WILL BE INVESTIGATED?
To evaluate mental symptoms, you will on two occasions have to answer nine questionnaires. The first concerns mental fatigue, the second examines symptoms such as anxiety and depression, and the third is based on eye disease. Numbers four and five are forms on quality of life. You will also have to answer three questionnaires about perceived stress and how to deal with it, as well as a short personality test.
Our study coordinator will take blood samples and our doctor and coordinator will review a range of background factors such as past and present illnesses, medication, data on Graves’ disease, treatment, smoking, alcohol, pregnancies, contraception, socioeconomics, heredity, and origin.
We will collect information from the medical record about your thyroid disease and possible recurrence and sick leave, as well as from the Swedish Social Insurance Agency’s register with regard to your sick leave/sickness compensation to investigate how the disease has affected your ability to work.
For those who wish to agree to it, the doctor will also perform a sampling of the spinal fluid through a needle in the back. In some of the study participants, we will do an in-depth study of brain activity. This is done partly with magnetoencephalography (MEG) and partly with a magnetic camera examination that is done at both visits. You will be asked separately about the MEG part when it has started.
The study is performed at diagnosis and after 15-18 months.