Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

Официальное название

Validating Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Graves' Disease and Their Association With Functional Changes in Neuronal Activation

Обзор

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.

Первичные конечные точки

• Identifying the immunological markers in blood at inclusion that significantly increases the risk for mental fatigue at follow up. [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]

Вторичные конечные точки (12)

• Levels of the previously identified immunological markers in serum at inclusion compared between participants who at follow up have high scores at the Mental Fatigue Scale and participants who at follow up have low scores at the Mental Fatigue Scale [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of the previously identified immunological markers in cerebrospinal fluid at inclusion compared between patients with high and low scores at the Mental Fatigue Score at follow-up [Срок оценки: Cerebrospinal fluid drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion]
• Levels of the previously identified immunological markers in serum at follow up compared between patients with high and low scores at the Mental Fatigue Scale at follow-up and to healthy controls [Срок оценки: Blood drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of the previously identified immunological markers in cerebrospinal fluid at follow up compared between patients with high and low scores at the Mental Fatigue Scale at follow-up [Срок оценки: Cerebrospinal fluid drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of thyroid hormones at inclusion compared in patients with high and low scores at the Mental Fatigue Scale at follow-up [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of thyroid hormones at inclusion compared in patients with high and low scores at the Mental Fatigue Scale at inclusion [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at inclusion.]
• Levels of thyroid antibodies at inclusion compared in patients with high and low scores at the Mental Fatigue Scale at follow-up [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of thyroid antibodies at inclusion compared in patients with high and low scores at the Mental Fatigue Scale at inclusion [Срок оценки: Blood drawn at inclusion. Mental Fatigue Scale completed by participants at inclusion.]
• Levels of thyroid antibodies at follow-up compared in patients with high and low scores at the Mental Fatigue Scale at follow-up. [Срок оценки: Blood drawn and Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of biomarkers indicating organic and structural nerve damage at inclusion in patients with high and low scores at the Mental Fatigue Scale at follow-up [Срок оценки: Blood and, in a subgroup, cerebrospinal fluid drawn at inclusion. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]
• Levels of biomarkers indicating organic and structural nerve damage at inclusion in patients with high and low scores at the Mental Fatigue Scale at inclusion [Срок оценки: Blood and, in a subgroup, cerebrospinal fluid, drawn at inclusion. Mental Fatigue Scale completed by participants at inclusion.]
• Levels of biomarkers indicating organic and structural nerve damage at follow-up in patients with high and low scores at the Mental Fatigue Scale at follow-up [Срок оценки: Blood and, in a subgroup, cerebrospinal fluid, drawn at follow-up after 15 months. Mental Fatigue Scale completed by participants at follow-up 15 months after inclusion.]

Критерии участия

Критерии включения

• 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

Controls: Matched for gender and age

Критерии исключения

• Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
• Recidive of Graves' disease
• Pregnancy

Controls: -Thyroid disease

• Neurological disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 1 центр

• Endokrina Forskningsenheten, Sahlgrenska University Hospital — Gothenburg

Идентификаторы

NCT: NCT06081439 · ImmunoGraves wp2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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