COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Fatigue, Depression, and Cortical Excitability in Systemic Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03165682
Recruitment Status : Unknown
Verified May 2018 by Mary Jacob Ross, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : May 11, 2018
Information provided by (Responsible Party):
Mary Jacob Ross, Assiut University

Brief Summary:

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

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Lupus

Group 1
Twenty-five patients with Systemic Lupus Erythematosus with prominent fatigue symptoms ( inclusion criterion: FSS of at least 4)
Group 2
Twenty-five patients with Systemic Lupus Erythematosus without subjectively enhanced fatiguability
Group 3
Twenty-five age, sex and educationally matched controls among the health worker.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
not related

Inclusion Criteria:

  • All the participants:

    1. 18 years of age or older.
    2. For Systemic lupus patients: have a stable drug regimen for 3 months prior to study entry; disease duration for at least 6 months or longer
    3. able to give written consent for participation.
    4. able to understand and respond the questionnaires.
    5. be free of serious comorbid medical conditions such as diabetes, congestive heart failure, renal failure, cancer, or fibromyalgia, which would confound interpretations of health status; and not pregnant.

Exclusion Criteria:

  • Any patient will meet any of these conditions will be excluded from the study, that including:

    1. Patient less than 18 years old.
    2. Patients with a definite diagnosis of any other systemic autoimmune disorders.
    3. History of any other neurologic disease, seizure or major medical disorders including heart failure, respiratory compromise, renal insufficiency, hepatic dysfunction, diabetes mellitus, malignancy, or endocrinal disturbance.
    4. Other contraindications of Transcranial Magnetic Stimulation as:

      1. Personal or family history of epilepsy, brain tumor, brain injury.
      2. History of metallic particles in the eye or head outside the mouth,
      3. Cardiac pacemakers, implanted neurostimulators, cochlear implants, implanted medication pumps.
      4. History of drug or alcohol abuse.
      5. Pregnancy.
      6. Comedication with neuroleptics and tricyclic antidepressants (amitriptyline etc.)
      7. Patients with increased intracranial pressure (which lowers seizure threshold intracardiac line).
      8. Significant heart disease: extensive ischemia.
      9. Bipolar disorder.
      10. History of stroke or other brain lesions.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03165682

Layout table for location contacts
Contact: Eman H. Khedr, Professor Dr. 00201005850632
Contact: Sounia M. Rashad, Professor Dr. 00201005451230

Sponsors and Collaborators
Assiut University
Layout table for investigator information
Study Director: Rania M. Gamal-El Din, Assistant Professor Dr Assiut University
Study Director: Eman M. El-Hakeem, Lecturer Dr Assiut University
Publications of Results:
Layout table for additonal information
Responsible Party: Mary Jacob Ross, Principal investigator, Assiut University Identifier: NCT03165682    
Other Study ID Numbers: FDCS
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Jacob Ross, Assiut University:
cortical excitability
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Behavioral Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases