Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）

NCT07626229 | Active Not Recruiting DMC

• 1 other identifier: DEMAND
• Study Type: interventional
• Target: 1,360
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Nervous System Diseases

Keywords

Large Language Model; Emergency Neurology; Diagnostic; Acute Neurological Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30

Secondary Outcomes (6)

• Diagnostic discrepancy

  Day 30

• Quality of diagnostic testing and management recommendations

  Day 30

• Patient satisfaction with emergency care

  Immediately after the index emergency department encounter, within 48 hours

• Time spent per patient encounter

  Time from start of physician evaluation to completion of final diagnosis and disposition decision, within 48 hours.

• Clinician-reported workload

  Immediately after each index emergency department encounter, within 48 hours.

Other Outcomes (3)

• Unplanned medical care within 30 days

  From completion of the index emergency department encounter to Day 30

• Harms related to this emergency care within 30 days

  From completion of the index emergency department encounter to Day 30

• All-cause death within 30 days

  From completion of the index emergency department encounter to Day 30

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Physicians in this group will use Xuanwu-NeuroAid 2.0 during emergency evaluation and management.

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.

Interventions

Xuanwu-NeuroAid 2.0 DEVICE

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.

AI-assisted group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (3)

Nanyang Nanshi Hospital

Nanyang, Henan, 473000, China

Location

Liuyang Jili Hospital

Guankou, Hunan, 410300, China

Location

Xuanwu Hospital，Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Nervous System Diseases; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 4, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

CN (3)