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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
Sponsor:
Information provided by (Responsible Party):
Mary Jacob Ross, Assiut University

Tracking Information
First Submitted Date May 20, 2017
First Posted Date May 24, 2017
Last Update Posted Date May 10, 2018
Estimated Study Start Date December 1, 2018
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03165682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fatigue, Depression, and Cortical Excitability in Systemic Lupus
Official Title Fatigue, Depression, and Cortical Excitability Changes in Systemic Lupus Erythematosus
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population not related
Condition Systemic Lupus Erythematosus
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 23, 2017)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Eman H. Khedr, Professor Dr. 00201005850632 Emankhedr99@yahoo.com
Contact: Sounia M. Rashad, Professor Dr. 00201005451230 souniarashad@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03165682
Other Study ID Numbers FDCS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mary Jacob Ross, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Rania M. Gamal-El Din, Assistant Professor Dr Assiut University
Study Director: Eman M. El-Hakeem, Lecturer Dr Assiut University
PRS Account Assiut University
Verification Date May 2018