Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06081439
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-09-28
Brief Title:
Validating Immunological Markers Associated With Mental Fatigue in Graves Disease
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Validating Immunological Markers in Blood and Cerebrospinal Fluid Associated With Mental Fatigue in Graves Disease and Their Association With Functional Changes in Neuronal Activation
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None