Fatigue, Depression, and Cortical Excitability in Systemic Lupus

May 8, 2018 updated by: Mary Jacob Ross, Assiut University

Fatigue, Depression, and Cortical Excitability Changes in Systemic Lupus Erythematosus

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

not related

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Rania M. Gamal-El Din, Assistant Professor Dr, Assiut University
  • Study Director: Eman M. El-Hakeem, Lecturer Dr, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

May 20, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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