Systemic Lupus ErythematosusNCT06226324
fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- neuropsychological test
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: There were 80 SLE patients (40 with and without neuropsychiatric symptoms) and 40 healthy controls
Who may be able to join
- Age and gender matched the case group
- Right-handed
- No cerebrovascular, neurological or mental diseases
- Can cooperate with MRI and neuropsychiatric examination
Who cannot join
- Patients with serious diseases of other systems
- Patients with diseases of central nervous system
- Other rheumatic immune system diseases
- Neuropsychiatric history
- Smokers, drug users or alcoholics
- Contraindicated MRI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Peng fei Qiao, 15904718239, 24853170@qq.com
Peng fei Qiao
About this study
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main cause of death. Cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. Studies have shown that the prevalence of NPSLE is between 37% and 95%. Compared with SLE patients, the mortality rate increases by three times. Early diagnosis and treatment play an important role in improving the quality of life of patients. fMRI has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. This study uses fMR to compare the differences in brain function changes between SLE patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.
Read the detailed description
The fMRI images of 40 SLE patients with neuropsychiatric symptoms, 40 SLE patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fMRI was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in SLE. Neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of SLE patients were collected, and the correlation between SLE patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of NPSLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- neuropsychological test
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testOther
The subjects were evaluated for memory, cognition, mood and sleep
| Study group | Role | What they receive |
|---|---|---|
| SLE with neuropsychiatric symptoms | 1. Neuropsychiatric symptoms meeting the 1999 ACR definition
2. Ages 18-55y
3. Female
4. Right-handed
5. Can cooperate with MRI and neuropsychiatric examination Receives: Other: neuropsychological test | |
| SLE without neuropsychiatric symptoms | 1. Patients who meet the 2019 ACR diagnostic criteria for SLE
2. Patients without neuropsychiatric symptoms
3. Age 18-55y
4. Female
5. Right-handed
6. Able to cooperate with MRI and neuropsychiatric examination Receives: Other: neuropsychological test | |
| Healthy control group | 1. Age and gender matched the case group
2. Right-handed
3. No cerebrovascular, neurological or mental diseases
4. Can cooperate with MRI and neuropsychiatric examination Receives: Other: neuropsychological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
Early identification of specific brain areas of brain injury in lupus patients by fMRI provides objective imaging markers for early clinical intervention.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng fei Qiao, Study director, The Affiliated Hospital of Inner Mongolia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226324
- Sponsor's protocol ID
- AHInnerMongolia-SLE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ni S, An N, Li C, Ma Y, Qiao P, Ma X. Altered structural and functional homotopic connectivity associated with cognitive changes in SLE. Lupus Sci Med. 2024 Nov 24;11(2):e001307. doi: 10.1136/lupus-2024-001307.
PubMed 39581701
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06226324
- Acronym / sponsor ID
- AHInnerMongolia-SLE
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jan 2024 (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 (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main cause of death. Cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. Studies have shown that the prevalence of NPSLE is between 37% and 95%. Compared with SLE patients, the mortality rate increases by three times. Early diagnosis and treatment play an important role in improving the quality of life of patients. fMRI has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. This study uses fMR to compare the differences in brain function changes between SLE patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.
Detailed description
The fMRI images of 40 SLE patients with neuropsychiatric symptoms, 40 SLE patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fMRI was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in SLE. Neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of SLE patients were collected, and the correlation between SLE patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of NPSLE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE with neuropsychiatric symptoms | – | Other: neuropsychological test1. Neuropsychiatric symptoms meeting the 1999 ACR definition 2. Ages 18-55y 3. Female 4. Right-handed 5. Can cooperate with MRI and neuropsychiatric examination |
| SLE without neuropsychiatric symptoms | – | Other: neuropsychological test1. Patients who meet the 2019 ACR diagnostic criteria for SLE 2. Patients without neuropsychiatric symptoms 3. Age 18-55y 4. Female 5. Right-handed 6. Able to cooperate with MRI and neuropsychiatric examination |
| Healthy control group | – | Other: neuropsychological test1. Age and gender matched the case group 2. Right-handed 3. No cerebrovascular, neurological or mental diseases 4. Can cooperate with MRI and neuropsychiatric examination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- There were 80 SLE patients (40 with and without neuropsychiatric symptoms) and 40 healthy controls
Key inclusion criteria (4 listed)
- Age and gender matched the case group
- Right-handed
- No cerebrovascular, neurological or mental diseases
- Can cooperate with MRI and neuropsychiatric examination
Key exclusion criteria (6 listed)
- Patients with serious diseases of other systems
- Patients with diseases of central nervous system
- Other rheumatic immune system diseases
- Neuropsychiatric history
- Smokers, drug users or alcoholics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological testThe subjects were evaluated for memory, cognition, mood and sleep | Other | Healthy control group, SLE with neuropsychiatric symptoms, SLE without neuropsychiatric symptoms |
Primary outcome
fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus
Time frame: 2 years
Early identification of specific brain areas of brain injury in lupus patients by fMRI provides objective imaging markers for early clinical intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 39581701Ni S, An N, Li C, Ma Y, Qiao P, Ma X. Altered structural and functional homotopic connectivity associated with cognitive changes in SLE. Lupus Sci Med. 2024 Nov 24;11(2):e001307. doi: 10.1136/lupus-2024-001307.
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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.
Peng fei Qiao study director
The Affiliated Hospital of Inner Mongolia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
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 4 inclusion and 6 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Peng fei Qiao (15904718239, 24853170@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus (time frame: 2 years). 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 NCT06226324, which also lists 1 linked publication.
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 26 Jan 2024.