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Validating immunological markers in blood and cerebrospinal fluid associated with mental fatigue in Graves' disease and their association with functional changes in neuronal activation

NCT ID NCT06081439

NEW Sponsor: Vastra Gotaland Region Source: ClinicalTrials.gov ↗

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 430 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

310 patients with Graves' are recruited from Endocrine Clinic at Sahlgrenska University Hospital and Östra Hospital. Patients meeting the inclusion criteria are consecutively asked to participate. A subgroup of maximum 120 patients who are willing to give cerebrospinal fluid are recruited to the sub-study with magnetoencephalography. Controls to this sub-study are recruited from records from the tax authority.

Ages

18 to 72 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Graves disease Mental Fatigue

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves' disease Mental fatigue

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Endokrina Forskningsenheten, Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 41346, Sweden

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