Fatigue, Depression, and Cortical Excitability in Systemic Lupus

NCT ID: NCT03165682

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-12-30

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.

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1

Twenty-five patients with Systemic Lupus Erythematosus with prominent fatigue symptoms ( inclusion criterion: FSS of at least 4)

No interventions assigned to this group

Group 2

Twenty-five patients with Systemic Lupus Erythematosus without subjectively enhanced fatiguability

No interventions assigned to this group

Group 3

Twenty-five age, sex and educationally matched controls among the health worker.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mary Jacob Ross

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania M. Gamal-El Din, Assistant Professor Dr

Role: STUDY_DIRECTOR

Assiut University

Eman M. El-Hakeem, Lecturer Dr

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Eman H. Khedr, Professor Dr.

Role: CONTACT

Emankhedr99@yahoo.com

00201005850632

Sounia M. Rashad, Professor Dr.

Role: CONTACT

souniarashad@gmail.com

00201005451230

References

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.

Reference Type: RESULT

PMID: 16320320 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12905462 (View on PubMed)

Other Identifiers

FDCS

Identifier Type: -

Identifier Source: org_study_id