NeurologyNCT07344792
Physician Diagnosis of Neurologic Cases With Large Language Models
A study testing LLM assistance in people with Neurology, run by Capital Medical University at 3 sites in China.
Trial summary
This study is a prospective randomized controlled trial that aims to evaluate whether large language model (LLM) assistance improves physicians' diagnostic performance compared with conventional assistance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurology
- What is being tested?
- LLM assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- 17 Jan 2026to 28 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Licensed physicians who have completed at least two years of neurology training.
- Willing to participate in the study and able to provide written informed consent.
Who cannot join
- Physicians who have previously participated in the development of the in-house LLM or the construction of datasets used in this study.
- Physicians who were involved in the clinical care of patients whose cases were used to construct the case dataset for this study.
- Physicians who are known to have previously reviewed or been exposed to the specific cases used in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Nanyang Central Hospital
Nanyang, Henan, 473000
About this study
Official title: Physician Diagnosis of Neurologic Cases Assisted by Large Language Models: A Randomized Controlled Trial
This study is a prospective randomized controlled trial that aims to evaluate whether large language model (LLM) assistance improves physicians' diagnostic performance compared with conventional assistance.
Read the detailed description
The study population consists of licensed physicians who have completed at least two years of neurology training. Participants are randomly assigned in a 1:1 ratio to the LLM assistance group or the conventional assistance group. In the LLM assistance group, physicians are assisted by an in-house LLM and are allowed to use conventional resources (e.g., search engines, UpToDate, or clinical guidelines) before submitting a final diagnosis. Access to any other LLMs is not permitted. In the conventional assistance group, physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. The primary outcome is top-1 diagnostic accuracy. Secondary outcomes include top-3 diagnostic accuracy, the time required to complete each case, and physicians' diagnostic confidence.
- Conditions
- Neurology
- Being tested
- LLM assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM assistanceOther
Physicians are assisted by an in-house large language model and are allowed to use conventional resources. Access to any other LLMs is not permitted.
| Study group | Role | What they receive |
|---|---|---|
| LLM assistance group | Experimental | Physicians are assisted by an in-house LLM and are allowed to use conventional resources. Access to any other LLMs is not permitted. Receives: Other: LLM assistance |
| Conventional assistance group | No intervention | Physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Top-1 diagnostic accuracy
Top-1 diagnosis is considered correct if the physician's final top-ranked diagnosis matches the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists.
Measured: Baseline
Secondary outcomes (3)
Top-3 diagnostic accuracy
Top-3 diagnosis is considered correct if the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists appears among the physician's top three final diagnoses.
Measured: Baseline
Time spent on diagnosis
Time participants spend per case.
Measured: Baseline
Diagnostic confidence
Physicians' diagnostic confidence will be measured using a five-point Likert scale (1=very unsure, 5=very sure).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Jan 2026
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurologyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT07344792
- Sponsor's protocol ID
- LLM-001
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Diagnosis of Neurologic Cases Assisted by Large Language Models: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344792
- Acronym / sponsor ID
- LLM-001
- Conditions
- Neurology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 15 Jan 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 is a prospective randomized controlled trial that aims to evaluate whether large language model (LLM) assistance improves physicians' diagnostic performance compared with conventional assistance.
Detailed description
The study population consists of licensed physicians who have completed at least two years of neurology training. Participants are randomly assigned in a 1:1 ratio to the LLM assistance group or the conventional assistance group. In the LLM assistance group, physicians are assisted by an in-house LLM and are allowed to use conventional resources (e.g., search engines, UpToDate, or clinical guidelines) before submitting a final diagnosis. Access to any other LLMs is not permitted. In the conventional assistance group, physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. The primary outcome is top-1 diagnostic accuracy. Secondary outcomes include top-3 diagnostic accuracy, the time required to complete each case, and physicians' diagnostic confidence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM assistance group | Experimental | Other: LLM assistancePhysicians are assisted by an in-house LLM and are allowed to use conventional resources. Access to any other LLMs is not permitted. |
| Conventional assistance group | No intervention | –Physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Licensed physicians who have completed at least two years of neurology training.
- Willing to participate in the study and able to provide written informed consent.
Key exclusion criteria (3 listed)
- Physicians who have previously participated in the development of the in-house LLM or the construction of datasets used in this study.
- Physicians who were involved in the clinical care of patients whose cases were used to construct the case dataset for this study.
- Physicians who are known to have previously reviewed or been exposed to the specific cases used in this study.
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 |
|---|---|---|
| LLM assistancePhysicians are assisted by an in-house large language model and are allowed to use conventional resources. Access to any other LLMs is not permitted. | Other | LLM assistance group |
Primary outcome
Top-1 diagnostic accuracy
Time frame: Baseline
Top-1 diagnosis is considered correct if the physician's final top-ranked diagnosis matches the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists.
3 secondary outcomes
Top-3 diagnostic accuracy
Time frame: Baseline
Time spent on diagnosis
Time frame: Baseline
Diagnostic confidence
Time frame: Baseline
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 29 Jan 2026.
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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 LLM assistance in people with Neurology, 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 2 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: finished, as of the sponsor's last update on 29 Jan 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?
Top-1 diagnostic accuracy (time frame: Baseline). 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 29 Jan 2026.