Nervous System DiseasesNCT07626229
Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）
A study testing Xuanwu-NeuroAid 2.0 in people with Nervous System Diseases, run by Capital Medical University at 3 sites in China.
Trial summary
This study will evaluate whether Xuanwu-NeuroAid 2.0, a large language model for emergency neurology, can improve 30-day diagnostic quality in adults with acute neurological symptoms. Physicians will be randomly assigned to AI-assisted care or usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- Xuanwu-NeuroAid 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,381 participants
- Where
- 3 sitesChina
- Study dates
- 9 Jun 2026to 6 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Presentation to the emergency neurology service with acute neurological symptoms;
- Written informed consent provided by the patient or a legally authorized representative.
Who cannot join
- Presentation primarily for trauma;
- Pregnancy;
- Requiring immediate life-saving interventions;
- Estimated life expectancy of less than 30 days;
- Participation in another clinical trial within the previous 30 days or in a trial that could interfere with the study or outcome assessment;
- Any condition that, in the opinion of the investigators, would interfere with the conduct of the trial or the interpretation of the results.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Xuanwu Hospital，Capital Medical University
Beijing, 100053
Liuyang Jili Hospital
Guankou, Hunan, 410300
Nanyang Nanshi Hospital
Nanyang, Henan, 473000
About this study
Official title: Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment: A Randomized Controlled Clinical Trial
This study will evaluate whether Xuanwu-NeuroAid 2.0, a large language model for emergency neurology, can improve 30-day diagnostic quality in adults with acute neurological symptoms. Physicians will be randomly assigned to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions, while physicians will make all final clinical decisions. The usual-care group will receive standard emergency neurology care without large language model assistance.
Read the detailed description
This multicenter, prospective, cluster randomized trial will evaluate whether Xuanwu-NeuroAid 2.0, a domain-specific large language model for emergency neurology, can improve diagnostic quality in adults presenting with acute neurological symptoms. Physicians will be randomized to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions based on available clinical information, while physicians will remain responsible for all final clinical decisions. the model's recommendations could be disregarded when they were considered inappropriate. The usual-care group will receive standard emergency neurology care without large language model assistance.
- Conditions
- Nervous System Diseases
- Being tested
- Xuanwu-NeuroAid 2.0
- Keywords
- Large Language Model, Emergency Neurology, Diagnostic, Acute Neurological Symptoms
- Medical subject headings
- Nervous System Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanwu-NeuroAid 2.0Device
Xuanwu-NeuroAid 2.0 is a large language model used to support emergency neurology evaluation and management. It generates diagnostic and management suggestions based on available clinical information, including history, physical examination, laboratory results, and imaging data. Physicians may interact with the model multiple times, but remain responsible for all final clinical decisions. Its recommendations may be overridden when considered inappropriate.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted group | Experimental | Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management. Receives: Device: Xuanwu-NeuroAid 2.0 |
| Usual-care group | No intervention | Physicians in this group will provide standard emergency neurology care without large language model assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic-care quality risk
A composite outcome defined as the occurrence of any of the following: a diagnostic discrepancy within 30 days; unplanned medical care within 30 days; harms related to the index emergency care within 30 days; or all-cause death within 30 days.
Measured: Day 30
Secondary outcomes (6)
Diagnostic discrepancy
Diagnostic discrepancy is defined as disagreement between the emergency department final diagnosis and the 30-day expert-adjudicated reference diagnosis.
Measured: Day 30
Quality of diagnostic testing and management recommendations
The quality of diagnostic testing and management recommendations made during the index emergency department encounter will be assessed by blinded expert adjudicators after completion of 30-day follow-up, using a 5-point Likert scale. Higher scores indicate higher quality of diagnostic testing and management recommendations.
Measured: Day 30
Patient satisfaction with emergency care
Patient satisfaction with emergency care will be assessed after the index emergency department encounter using a 5-point Likert scale, ranging from 1 to 5, with higher scores indicating greater satisfaction.
Measured: Immediately after the index emergency department encounter, within 48 hours
Time spent per patient encounter
Time spent per patient encounter is defined as the duration from the start of physician evaluation to completion of the emergency department final diagnosis and disposition decision during the index emergency department encounter.
Measured: Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.
Clinician-reported workload
Clinician-reported workload will be assessed by the treating physician using a single-item 5-point Likert scale, ranging from 1 to 5. Higher scores indicate greater perceived workload.
Measured: Immediately after each index emergency department encounter, within 48 hours.
EQ-5D-5L at 30 days
Health-related quality of life will be assessed using the EuroQol five-dimension five-level questionnaire. The EQ-5D-5L utility index score will be derived according to the applicable value set. The maximum score is 1, indicating full health; higher scores indicate better health status.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start9 Jun 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626229
- Sponsor's protocol ID
- DEMAND
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07626229
- Acronym / sponsor ID
- DEMAND
- Conditions
- Nervous System Diseases
- Keywords
- Large Language Model, Emergency Neurology, Diagnostic, Acute Neurological Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,381 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 4 Jun 2026 (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.
This study will evaluate whether Xuanwu-NeuroAid 2.0, a large language model for emergency neurology, can improve 30-day diagnostic quality in adults with acute neurological symptoms. Physicians will be randomly assigned to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions, while physicians will make all final clinical decisions. The usual-care group will receive standard emergency neurology care without large language model assistance.
Detailed description
This multicenter, prospective, cluster randomized trial will evaluate whether Xuanwu-NeuroAid 2.0, a domain-specific large language model for emergency neurology, can improve diagnostic quality in adults presenting with acute neurological symptoms. Physicians will be randomized to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions based on available clinical information, while physicians will remain responsible for all final clinical decisions. the model's recommendations could be disregarded when they were considered inappropriate. The usual-care group will receive standard emergency neurology care without large language model assistance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted group | Experimental | Device: Xuanwu-NeuroAid 2.0Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management. |
| Usual-care group | No intervention | –Physicians in this group will provide standard emergency neurology care without large language model assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years;
- Presentation to the emergency neurology service with acute neurological symptoms;
- Written informed consent provided by the patient or a legally authorized representative.
Key exclusion criteria (6 listed)
- Presentation primarily for trauma;
- Pregnancy;
- Requiring immediate life-saving interventions;
- Estimated life expectancy of less than 30 days;
- Participation in another clinical trial within the previous 30 days or in a trial that could interfere with the study or outcome assessment;
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 |
|---|---|---|
| Xuanwu-NeuroAid 2.0Xuanwu-NeuroAid 2.0 is a large language model used to support emergency neurology evaluation and management. It generates diagnostic and management suggestions based on available clinical information, including history, physical examination, laboratory results, and imaging data. Physicians may interact with the model multiple times, but remain responsible for all final clinical decisions. Its recommendations may be overridden when considered inappropriate. | Device | AI-assisted group |
Primary outcome
Diagnostic-care quality risk
Time frame: Day 30
A composite outcome defined as the occurrence of any of the following: a diagnostic discrepancy within 30 days; unplanned medical care within 30 days; harms related to the index emergency care within 30 days; or all-cause death within 30 days.
6 secondary outcomes
Diagnostic discrepancy
Time frame: Day 30
Quality of diagnostic testing and management recommendations
Time frame: Day 30
Patient satisfaction with emergency care
Time frame: Immediately after the index emergency department encounter, within 48 hours
Time spent per patient encounter
Time frame: Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.
Clinician-reported workload
Time frame: Immediately after each index emergency department encounter, within 48 hours.
EQ-5D-5L at 30 days
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xuanwu-NeuroAid 2.0 in people with Nervous System Diseases, run by Capital Medical University at 3 sites 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 3 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic-care quality risk (time frame: Day 30). 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 7 Aug 2026.