Actively Recruiting

Age: 18Years - 72Years
FEMALE
Healthy Volunteers
ID05678374

Exploring Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Euthyroidism After Graves' Disease - a Cross Sectional Study

Led by Vastra Gotaland Region · Updated on 2025-09-29

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating mental fatigue, a common but poorly understood symptom in many diseases, focusing on its occurrence after treatment of Graves' disease. They suspect that this lingering mental fatigue may be due to an autoimmune response. This observational study aims to identify immune system markers linked to mental fatigue in women who have been treated for Graves' disease, with plans to validate these findings in future research. The study also compares these patients to thyroid-healthy women without mental fatigue. Participants are divided into three groups: women diagnosed with Graves' disease 15 to 60 months ago who have mental fatigue, women with Graves' disease in the same timeframe without mental fatigue, and healthy women without thyroid disease or mental fatigue. Each participant is assessed once for thyroid hormone levels, quality of life, anxiety, depression, stress, coping strategies, eye symptoms, and background information. Blood and cerebrospinal fluid samples are pooled and analyzed to detect antibodies that may target brain proteins, especially those more common in patients with mental fatigue. During the single visit, researchers will collect questionnaires and biological samples to measure various immune markers, thyroid antibodies, cytokines, nerve damage indicators, and self-reported mental and physical health factors. They will also examine the prevalence of eye disease linked to Graves' and compare quality of life, anxiety, depression, stress, coping, optimism, and personality traits among the groups. The primary goal is to find antibodies associated with mental fatigue in Graves' disease. The study is conducted in women aged 18 to 72 years and is expected to continue until December 2028.

CONDITIONS

Brief Title

Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Who Can Participate

Age: 18Years - 72Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • If patient: Graves' disease with positive TSH-receptor antibodies and thyroid hormones above the upper reference limit at diagnosis
  • Diagnosis 15 to 60 months ago; if recurrence, both episodes must be within 15 to 60 months
  • Thyroid hormones within normal range without anti-thyroid drugs
  • If control: No thyroid disease
  • Patient and control without mental fatigue: Mental Fatigue Score 8 (cut off 10.5)
  • Patient with mental fatigue: Mental Fatigue Score >13 and symptom onset coinciding with Graves' disease, without other obvious cause
Not Eligible

You will not qualify if you...

  • Unable to follow protocol
  • Multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, or other neurological disease
  • Traumatic brain injury with unconsciousness
  • Other diseases strongly associated with fatigue
  • Pregnancy or breast-feeding
  • On-going or recent systemic steroid treatment
  • Radioiodine therapy within the last 18 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo assessment to identify immunological markers and complete self-evaluations related to mental fatigue and thyroid health.

1 visit (in-person)

Long-term Monitoring

Duration - Single occasion examination for patients diagnosed 15 to 60 months ago

Participants are observed to compare autoantibodies, biomarkers, and quality of life measures across groups.

No additional visits

Trial Site Locations

Total: 1 location

1

Department of Endocrinology, Sahlgrenska University Hospital

Gothenburg, Sweden, 41346

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Research Team

K

Karin Tammelin

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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