Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-72
SponsorVastra Gotaland Region

About this trial

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored euthyroidism in Graves' disease is an autoimmune complication. This is a confirmatory study of the biomarkers from ImmunoGraves WP1 in which immunological markers with possible association with mental fatigue in Graves' disease are explored.

In ImmunoGraves WP2, 310 patients with Graves' disease are assessed for symptoms of mental fatigue, quality of life, anxiety and depression, self-evaluated stress, coping strategies, personality traits, eye symptoms and background variables. Participants are examined in hyperthyroidism at inclusion, within three weeks from diagnosis, and in euthyroidism after 15 months. Serum and cerebrospinal fluid (in a subsample of participants) is collected at both visits and will be evaluated for the immunological markers identified in WP1 as well as for thyroid hormones, thyroid autoantibodies and biomarkers indicating organic and structural nerve damage. Significant predictors for mental fatigue will be identified by logistic regression.

To assess functional changes in the brain, magnetoencephalography will be performed in a subset of patients and in healthy controls at inclusion and after 15 to 18 months. Combined with magneto resonance imaging (MRI), magnetoencephalography gives information on neuronal activation during attention testing.

Eligibility criteria

Qualifiers

Recently diagnosed Graves' disease

Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb)

Thyroid hormones above the upper reference limit

Inclusion within three weeks after start of antithyroid drugs

Disqualifiers

Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.

Recidive of Graves' disease

Pregnancy

Neurological disease

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

430 Participants
are grouped into 2 trial groups

Sponsors and collaborators