Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Launched by VASTRA GOTALAND REGION · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying mental fatigue in patients with Graves' disease, which is an autoimmune condition that affects the thyroid. The researchers believe that even after thyroid hormone levels return to normal, some patients continue to experience mental fatigue due to immune system factors. They want to find specific proteins in the blood and spinal fluid that could be linked to this fatigue. To do this, they will compare 60 patients who report mental fatigue with 60 patients who do not have this issue, along with 60 healthy individuals without thyroid disease.

To participate, individuals must have been diagnosed with Graves' disease between 15 to 60 months ago and be free of thyroid hormone treatments. Patients must also have a certain score on a mental fatigue questionnaire; those with scores above 13 are considered to have mental fatigue, while those scoring below 8 do not. Participants will undergo various assessments, including questionnaires about their quality of life, stress, and symptoms. It's important to note that individuals with certain neurological conditions or ongoing treatments that could affect fatigue are not eligible for the study. This research could help improve understanding of mental fatigue in Graves' disease and potentially lead to better treatments in the future.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • If patient: Graves' disease with positive TSH-receptor antibodies and thyroid hormones above the upper reference limit at diagnosis
• • Diagnosis15 to 60 months ago. If recidive both episodes must have occurred within 15 months 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 debut of symptoms of mental fatigue in parallel with debut of Graves' disease, without other obvious cause
• • Exclusion Criteria
• • Person unable to follow protocol
• • Multiple sclerosis, myalgic encephalomyelitis/chronic fatigue syndrome, any other neurological disease
• • Traumatic brain injury with unconsciousness
• • Other disease strongly associated with fatigue
• • Pregnancy and breast-feeding
• • On-going or recent systemic treatment with steroids
• • Radioiodine therapy within the last 18 months