Systemic Lupus ErythematosusNCT03165682
Fatigue, Depression, and Cortical Excitability in Systemic Lupus
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: not related
Who may be able to join
- All the participants:
- 18 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Keywords
- fatigue, depression, cortical excitability
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
Depression assessment among studied participants.
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Dec 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Jacob Ross, Assiut University
- Investigators
- Rania M. Gamal-El Din, Assistant Professor Dr, Study director, Assiut UniversityEman M. El-Hakeem, Lecturer Dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165682
- Sponsor's protocol ID
- FDCS
- Status last verified
- May 2018
- First submitted
- 20 May 2017
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16320320McMurray 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.
PubMed 12905462
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Depression, and Cortical Excitability Changes in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03165682
- Acronym / sponsor ID
- FDCS
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- fatigue, depression, cortical excitability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- not related
Key inclusion criteria (6 listed)
- All the participants:
Key exclusion criteria (15 listed)
- Any patient will meet any of these conditions will be excluded from the study, that including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Depression assessment among studied participants.
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Results publication: PubMed 16320320Li 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.
- Results publication: PubMed 12905462McMurray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania M. Gamal-El Din, Assistant Professor Dr study director
Assiut University
Eman M. El-Hakeem, Lecturer Dr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman H. Khedr, Professor Dr. (00201005850632, Emankhedr99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability assessment among studied participants. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165682, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.