Fatigue, Depression, and Cortical Excitability in Systemic Lupus

NCT03165682 | Unknown

• 1 other identifier: FDCS
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Keywords

fatigue; depression; cortical excitability

Outcome Measures

Primary Outcomes (1)

• Cortical excitability assessment among studied participants.

  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.

  six months

Secondary Outcomes (1)

• Depression assessment among studied participants.

  six months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

not related

You may qualify if:

• All the participants:
• years of age or older.
• 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
• able to give written consent for participation.
• able to understand and respond the questionnaires.
• 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.

You may not qualify if:

• Any patient will meet any of these conditions will be excluded from the study, that including:
• Patient less than 18 years old.
• Patients with a definite diagnosis of any other systemic autoimmune disorders.
• 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.
• Other contraindications of Transcranial Magnetic Stimulation as:
• Personal or family history of epilepsy, brain tumor, brain injury.
• History of metallic particles in the eye or head outside the mouth,
• Cardiac pacemakers, implanted neurostimulators, cochlear implants, implanted medication pumps.
• History of drug or alcohol abuse.
• Pregnancy.
• Comedication with neuroleptics and tricyclic antidepressants (amitriptyline etc.)
• Patients with increased intracranial pressure (which lowers seizure threshold intracardiac line).
• Significant heart disease: extensive ischemia.
• Bipolar disorder.
• History of stroke or other brain lesions.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Li J, May W, McMurray RW. Pituitary hormones and systemic lupus erythematosus. Arthritis Rheum. 2005 Dec;52(12):3701-12. doi: 10.1002/art.21436. No abstract available.

  PMID: 16320320 RESULT

• McMurray RW, May W. Sex hormones and systemic lupus erythematosus: review and meta-analysis. Arthritis Rheum. 2003 Aug;48(8):2100-10. doi: 10.1002/art.11105. No abstract available.

  PMID: 12905462 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue; Depression

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Rania M. Gamal-El Din, Assistant Professor Dr

  Assiut University

  STUDY DIRECTOR

• Eman M. El-Hakeem, Lecturer Dr

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Eman H. Khedr, Professor Dr.

CONTACT

00201005850632; Emankhedr99@yahoo.com

Sounia M. Rashad, Professor Dr.

CONTACT

00201005451230; souniarashad@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: May 24, 2017
• Study Start: December 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-05