Severe Autoimmune EncephalitisNCT06697678
Risk Prediction Model for Severe Autoimmune Encephalitis
An observational study of Severe Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing.
Trial summary
A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Severe Autoimmune Encephalitis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnostic criteria for autoimmune encephalitis (AE) patients (all four criteria must be met): A. clinical Presentation: acute or subacute onset (<3 months) with one or more neurological or psychiatric symptoms or clinical syndromes: a. limbic system symptoms b. encephalitis syndrome c. basal ganglia and/or diencephalon/hypothalamus involvement d. psychiatric disorders. B. auxiliary tests: presence of one or more of the following findings, or associated relevant tumors: a. abnormal cerebrospinal fluid (CSF) b. neuroimaging or electrophysiological abnormalities. C. confirmatory test: positive neuronal autoantibodies. D. exclusion of other causes: a reasonable exclusion of other potential etiologies.
Who may be able to join
- age 14-80 years
- no restriction on gender
- meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
- within 3 months of AE
- patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf
Who cannot join
- no lumbar puncture performed for CSF antibody testing
- did not receive immunotherapy
- pre-onset modified Rankin Scale (mRS) score ≥3
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis
A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.
Read the detailed description
To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.
- Conditions
- Severe Autoimmune Encephalitis
- Being tested
- No Intervention: Observational Cohort
- Keywords
- severe autoimmune encephalitis, prediction model, plasma exchange therapy, plasma adsorption therapy, targeted immunotherapy
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with severe autoimmune encephalitis | No intervention Receives: Other: No Intervention: Observational Cohort | |
| patients with non-severe autoimmune encephalitis | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
CASE
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Measured: 2 months of enrollment
Secondary outcomes (5)
CASE
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Measured: 1 month of enrollment
mRS
The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
Measured: 1 months, 2 months of enrollment
GCS
The unabbreviated scale title is Glasgow coma score. The GCS tested 3 components: eye opening response, verbal response and motor response, with a total score of 15. The lower the score, the more severe the brain damage and the deeper the degree of DOC.
Measured: 1 months, 2 months of enrollment
Prognostic scores (CASE)
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
Measured: 6 months, 12 months of enrollment
Prognostic scores (mRS)
The unabbreviated scale title is modified Rankin Scale. The mRS includes 0-6, and the higher the score, the worse the prognosis.
Measured: 6 months, 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Autoimmune EncephalitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697678
- Sponsor's protocol ID
- AE
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Severe Autoimmune Encephalitis
- ClinicalTrials.gov ID
- NCT06697678
- Acronym / sponsor ID
- AE
- Conditions
- Severe Autoimmune Encephalitis
- Keywords
- severe autoimmune encephalitis, prediction model, plasma exchange therapy, plasma adsorption therapy, targeted immunotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 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.
A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.
Detailed description
To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with severe autoimmune encephalitis | – | Other: No Intervention: Observational CohortNo intervention |
| patients with non-severe autoimmune encephalitis | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnostic criteria for autoimmune encephalitis (AE) patients (all four criteria must be met): A. clinical Presentation: acute or subacute onset (<3 months) with one or more neurological or psychiatric symptoms or clinical syndromes: a. limbic system symptoms b. encephalitis syndrome c. basal ganglia and/or diencephalon/hypothalamus involvement d. psychiatric disorders. B. auxiliary tests: presence of one or more of the following findings, or associated relevant tumors: a. abnormal cerebrospinal fluid (CSF) b. neuroimaging or electrophysiological abnormalities. C. confirmatory test: positive neuronal autoantibodies. D. exclusion of other causes: a reasonable exclusion of other potential etiologies.
Key inclusion criteria (5 listed)
- age 14-80 years
- no restriction on gender
- meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
- within 3 months of AE
- patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf
Key exclusion criteria (3 listed)
- no lumbar puncture performed for CSF antibody testing
- did not receive immunotherapy
- pre-onset modified Rankin Scale (mRS) score ≥3
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | patients with non-severe autoimmune encephalitis, patients with severe autoimmune encephalitis |
Primary outcome
CASE
Time frame: 2 months of enrollment
The unabbreviated scale title is the clinical assessment scale for autoimmune encephalitis. The CASE includes a total score of 0-27.The higher the score, the worse the prognosis.
5 secondary outcomes
CASE
Time frame: 1 month of enrollment
mRS
Time frame: 1 months, 2 months of enrollment
GCS
Time frame: 1 months, 2 months of enrollment
Prognostic scores (CASE)
Time frame: 6 months, 12 months of enrollment
Prognostic scores (mRS)
Time frame: 6 months, 12 months of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Autoimmune Encephalitis, run by Xuanwu Hospital, Beijing.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang (0086-13671376710, zhangylq@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CASE (time frame: 2 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.