Fatigue, Depression, and Cortical Excitability in Systemic Lupus
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|ClinicalTrials.gov Identifier: NCT03165682|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : May 10, 2018
Systemic lupus erythematosus is a chronic inflammatory autoimmune disease with an unknown cause and many challenges. Whilst corticosteroids and effective immunosuppressive therapy have transformed the management of patients with active systemic lupus erythematosus, one of the major causes of morbidity in Systemic lupus erythematosus patients is chronic, debilitating fatigue.
Despite frequent occurrence of fatigue in Systemic Lupus Erythematosus, to the best of our knowledge, no studies have been directly performed to examine fatigue-related changes in cortical motor function in Systemic lupus erythematosus. In this study, we hypothesized that Systemic lupus erythematosus patients with fatigue and depression versus Systemic lupus erythematosus patients without fatigue and depression would present an alteration of motor cortex excitability.
|Condition or disease|
|Systemic Lupus Erythematosus|
Fatigue, is a multidimensional phenomenon that affects individuals physically, emotionally, cognitively, and behaviorally.It affects 80-90% of patients with systemic lupus erythematosus. It is likely multifactorial and may be caused by disordered sleep, anxiety and depression, pain, polypharmacy, comorbidities, and possibly disease activity.
Additionally, fatigue is the most prevalent symptom in systemic lupus erythematosus, being present in up to 90% of patients. Moreover, fatigue has a major impact on the Health-Related Quality Of Life of Systemic lupus erythematosus patients through its impact on family life, work, social life, emotional wellbeing, and cognition. Therefore, every effort should be made to relieve fatigue in this population. Recommendations for the management of fatigue usually combine pharmacologic and nonpharmacologic interventions; however, no speciﬁc drugs have proven useful for treating fatigue in Systemic lupus erythematosus.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Fatigue, Depression, and Cortical Excitability Changes in Systemic Lupus Erythematosus|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Twenty-five patients with Systemic Lupus Erythematosus with prominent fatigue symptoms ( inclusion criterion: FSS of at least 4)
Twenty-five patients with Systemic Lupus Erythematosus without subjectively enhanced fatiguability
Twenty-five age, sex and educationally matched controls among the health worker.
- Cortical excitability assessment among studied participants. [ Time Frame: six months ]
Done by Transcranial Magnetic Stimulation :
For assessment of cortical excitability parameters (resting and active motor threshold Cortical Silent Period at different intensities) among studied participants.
- Depression assessment among studied participants. [ Time Frame: six months ]The Beck Depression Inventory (BDI), self-assessment question, is one of the most widely used instruments to evaluate the severity of depression. The results were evaluated by a psychiatrist.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165682
|Contact: Eman H. Khedr, Professor Dr.||00201005850632||Emankhedr99@yahoo.com|
|Contact: Sounia M. Rashad, Professor Dr.||firstname.lastname@example.org|
|Study Director:||Rania M. Gamal-El Din, Assistant Professor Dr||Assiut University|
|Study Director:||Eman M. El-Hakeem, Lecturer Dr||Assiut University|