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PolyneuropathiesREASONNCT07493681

ChatGPT in the Diagnosis and Management of Complex Polyneuropathies: Comparative Analysis With Neurologists Using Real-World Cases

An observational study of Polyneuropathies, run by Istituto Clinico Humanitas at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BACKGROUND AND PURPOSE Polyneuropathies are diseases affecting the peripheral nerves that occur in approximately 1% of the general population, rising to up to 13% among older adults. Despite their prevalence, accurate diagnosis is often challenging and requires specialist expertise that is not uniformly available. Read more about this study

Who is it for?
Any age
Conditions the study is for
Polyneuropathies
What is being tested?
ChatGPT-4o and chatGPT
How many people
100 participants
Where
1 siteItaly
Study dates
12 Jun 2023to 1 Mar 2025
How long will I take part?
12 Months
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Cases will be identified from patients with a confirmed diagnosis of polyneuropathy consecutively attending the polyneuropathy outpatient clinics of the two participating institutions. Demographic, clinical, and diagnostic data will be extracted from medical records at two time points: the initial neurological consultation and the first follow-up visit after completion of standard screening investigations, including laboratory tests and nerve conduction studies.

Who may be able to join

  • Confirmed diagnosis of polyneuropathy of any etiology
  • Final etiological diagnosis confirmed after at least 12 months of clinical follow-up
  • Availability of sufficient clinical, electrophysiological, and laboratory information in the medical record to allow preparation of a standardized case summary

Who cannot join

  • Absence of a confirmed etiological diagnosis (idiopathic neuropathy)

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Humanitas Research Hospital

    Milan, MI, 20089

Other trials in Italy

About this study

Official title: Role of ChatGPT in the Differential Diagnosis of Polyneuropathies and Comparison of Its Performance With That of Peripheral Neuropathy Specialists and Non-specialists

BACKGROUND AND PURPOSE Polyneuropathies are diseases affecting the peripheral nerves that occur in approximately 1% of the general population, rising to up to 13% among older adults. Despite their prevalence, accurate diagnosis is often challenging and requires specialist expertise that is not uniformly available. Patients evaluated in primary care or non-specialist settings frequently experience diagnostic delays or misdiagnoses, highlighting the need for innovative tools to support clinicians at critical points in the diagnostic process.

Artificial intelligence (AI) large language models (LLMs), such as ChatGPT, are increasingly being explored as potential aids in clinical diagnosis. These tools can process complex clinical information and generate diagnostic suggestions at low cost and with broad accessibility. However, their performance in specialised neurological conditions, particularly complex polyneuropathies, has not yet been rigorously evaluated in real-world settings.

Read more

STUDY OBJECTIVES This study aims to evaluate the diagnostic performance of ChatGPT-4o on real-world polyneuropathy cases and to compare it with that of peripheral nerve disease specialists and non-specialist neurologists. A secondary objective is to assess whether exposure to ChatGPT-4o outputs influences and potentially improves neurologist diagnostic accuracy.

STUDY DESIGN This will be a comparative diagnostic accuracy study conducted at two tertiary referral centres for peripheral neuropathies in Milan, Italy. One hundred patients with confirmed polyneuropathy diagnoses will be randomly selected from consecutive outpatients. Each case will be summarised in a standardised format including demographics, symptom history, neurological examination findings, nerve conduction study results, and screening laboratory data. Only cases with a diagnosis confirmed after at least 12 months of clinical follow-up will be included.

ChatGPT-4o will be presented with each case using a structured prompt, and will be asked to provide: (1) a leading diagnosis, (2) two alternative differential diagnoses, and (3) a single recommended confirmatory diagnostic test. The model will be run in two independent trials to assess response consistency.

The same 100 cases will also be reviewed by neurologists from multiple international centres. Participants will be classified as either peripheral nerve disease specialists, neurologists routinely practising in tertiary polyneuropathy centres, or non-specialists, including general neurologists or those sub-specialised in other fields. Neurologists will first provide their own diagnostic assessments independently, and will subsequently be shown ChatGPT-4o's output with the option to revise their responses.

EXPECTED SIGNIFICANCE This study will provide evidence on whether AI-based LLMs can serve as reliable diagnostic aids in complex polyneuropathy cases.

Read the detailed description

Background and Rationale Polyneuropathies represent a heterogeneous group of disorders affecting the peripheral nervous system and constitute one of the most common neurological conditions encountered in clinical practice. Their prevalence is estimated at approximately 1% in the general population and increases substantially with age, reaching nearly 4% among middle-aged individuals and up to 13% among the elderly. Peripheral neuropathies therefore represent a major contributor to neurological morbidity and healthcare utilization worldwide.

Establishing the etiological diagnosis of polyneuropathy remains clinically challenging. Despite advances in laboratory testing and neurophysiological techniques, the diagnostic process continues to rely heavily on careful clinical evaluation, including detailed patient history and neurological examination, followed by targeted use of electrophysiological and laboratory investigations. In many cases, accurate diagnosis requires specialized expertise in neuromuscular disorders.

Access to such expertise is unevenly distributed across healthcare systems. A substantial proportion of patients with peripheral neuropathies are initially evaluated by non-specialist physicians, including general neurologists or clinicians in primary or secondary care settings. Diagnostic delays and misclassification of neuropathy subtypes are therefore relatively common, particularly for rare or atypical etiologies. These challenges highlight the need for tools capable of supporting clinicians during the diagnostic process.

Recent advances in artificial intelligence (AI), particularly the development of large language models (LLMs), have generated increasing interest in their potential applications in clinical medicine. ChatGPT, developed by OpenAI and based on the Generative Pre-trained Transformer architecture, is a conversational AI system capable of generating context-aware medical reasoning and diagnostic suggestions. Emerging studies suggest that LLMs may achieve diagnostic performance comparable to that of medical trainees or physicians in certain clinical reasoning tasks.

However, rigorous evaluation of LLM performance in complex neurological conditions remains limited. In particular, little evidence exists regarding their performance in diagnostically challenging polyneuropathy cases typically encountered in tertiary referral centers. Evaluating the capabilities and limitations of such tools in this setting is essential before considering their potential role as clinical decision-support systems.

This study aims to systematically evaluate the diagnostic performance of ChatGPT-4o when applied to real-world polyneuropathy cases and to compare its performance with that of specialist and non-specialist neurologists.

Study Objectives The primary objective of this study is to evaluate the diagnostic accuracy of ChatGPT-4o in identifying the leading etiological diagnosis in complex polyneuropathy cases.

Specifically, the study aims to compare the diagnostic performance of ChatGPT-4o with that of peripheral nerve disease specialists and non-specialist neurologists.

Secondary objectives include assessing the ability of ChatGPT-4o to generate appropriate differential diagnoses and recommend suitable confirmatory diagnostic tests. The study will also evaluate whether exposure to AI-generated diagnostic suggestions influences neurologist diagnostic decisions. Additionally, the study will assess the consistency of ChatGPT-4o responses across repeated independent evaluations and characterize the types of errors produced by the model when incorrect diagnoses are generated.

Study Design This is a comparative diagnostic accuracy study designed to evaluate the performance of an artificial intelligence-based large language model relative to human neurologists.

The study will be conducted across two tertiary referral centers for peripheral neuropathies located in Milan, Italy: Humanitas Research Hospital (IRCCS) and Fondazione IRCCS Istituto Neurologico Carlo Besta. These institutions provide specialized care for patients with a wide range of polyneuropathies, including inflammatory, hereditary, metabolic, toxic, and paraneoplastic etiologies.

The study protocol has been approved by the Ethics Committee of Humanitas Research Hospital and will be conducted in accordance with the principles of the Declaration of Helsinki.

Study Population and Case Selection Clinical cases will be retrospectively identified from patients evaluated in the polyneuropathy outpatient clinics of the participating institutions. Eligible cases will include patients with a confirmed diagnosis of polyneuropathy for whom a stable etiological diagnosis has been established after at least 12 months of clinical follow-up.

Clinical information will be extracted from medical records and used to prepare standardized case summaries. Data included in the summaries will reflect the information typically available during early diagnostic evaluation, including patient demographics, clinical history, neurological examination findings, results of nerve conduction studies, and results of standard laboratory screening tests.

From the pool of eligible cases, 100 cases will be randomly selected using a computer-generated sampling method. All cases will be anonymized prior to analysis.

The final dataset is expected to include a broad spectrum of polyneuropathy etiologies reflecting the referral patterns of tertiary neuromuscular centers, including inflammatory neuropathies, hereditary neuropathies, metabolic neuropathies, toxic neuropathies, and other less common conditions.

Case Evaluation by ChatGPT-4o The artificial intelligence system evaluated in this study is ChatGPT-4o Enterprise, developed by OpenAI.

Each clinical case summary will be presented to the model using standardized prompts instructing the model to analyze the clinical scenario and provide diagnostic reasoning. For each case, the model will be asked to generate:

  • one leading etiological diagnosis,
  • two less likely alternative diagnoses,
  • and one diagnostic test capable of confirming the leading diagnosis. To minimize contextual bias, each case will be evaluated in an independent session with no prior conversation history. The entire dataset will be evaluated twice in two independent runs in order to assess the reproducibility and consistency of the model's responses.

Case Evaluation by Neurologists A panel of neurologists from multiple international centers will participate as human raters in the study. Participants will include both peripheral nerve disease specialists and neurologists without specific subspecialization in neuromuscular disorders.

Neurologists will review the same standardized case summaries using a web-based interface and will be asked to provide a leading diagnosis, two alternative differential diagnoses, and a recommended confirmatory diagnostic test for each case.

The evaluation will be conducted in two phases. In the first phase, neurologists will independently review the cases and provide their diagnostic assessments. In the second phase, cases will be presented again together with the diagnostic output generated by ChatGPT-4o, allowing neurologists to confirm or modify their previous responses. This design will allow assessment of the potential influence of AI-generated suggestions on physician diagnostic decisions.

Outcome Assessment The primary outcome of the study is diagnostic accuracy for the leading diagnosis, defined as the proportion of cases in which the proposed leading diagnosis matches the final confirmed etiological diagnosis.

Secondary outcomes include the accuracy of differential diagnoses, the appropriateness of recommended confirmatory diagnostic tests, and changes in neurologist diagnostic performance after reviewing AI-generated outputs.

All responses will be evaluated against the final confirmed diagnosis for each case. The appropriateness of differential diagnoses and diagnostic test recommendations will be independently assessed by expert neurologists with extensive experience in polyneuropathy diagnosis.

Clinical Significance This study will provide empirical evidence on the diagnostic performance of a large language model in a complex neurological domain. By directly comparing AI-generated diagnostic reasoning with that of specialist and non-specialist neurologists, the study aims to clarify the potential role of large language models as decision-support tools in neurology.

Being tested
ChatGPT-4o, chatGPT
Keywords
Polyneuropathies, Artificial Intelligence, Large Language Models, ChatGPT
Medical subject headings
Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChatGPT-4oOther

    ChatGPT-4o Enterprise (OpenAI) is evaluated as an artificial intelligence-based large language model for clinical diagnostic reasoning. Standardized anonymized clinical case summaries will be presented to the model, which will generate a leading diagnosis, two alternative differential diagnoses, and one recommended confirmatory diagnostic test for each case.

  • chatGPTOther

    Case summaries will

Study groups in NCT07493681
Study groupRoleWhat they receive
Polyneuropathy patientsPatients with a confirmed etiological diagnosis of polyneuropathy evaluated at tertiary neuromuscular referral centers. Clinical data from these patients will be used to generate standardized anonymized case summaries that will be evaluated by neurologists and by an artificial intelligence-based large language model (ChatGPT-4o) for diagnostic accuracy.
Receives: Other: ChatGPT-4o; Other: chatGPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Accuracy of Leading Diagnosis

    Proportion of cases in which the leading diagnosis proposed by ChatGPT-4o, specialist neurologists, or non-specialist neurologists matches the patient's final confirmed etiological diagnosis.

    Measured: through study completion, an average of 6 months

Secondary outcomes (3)
  1. Accuracy of Differential Diagnoses

    Proportion of cases in which the correct etiological diagnosis is included among the three diagnoses proposed (one leading diagnosis and two alternative differential diagnoses).

    Measured: through study completion, an average of 6 months

  2. Change in Neurologist Diagnostic Accuracy After AI Review

    Change in neurologist diagnostic accuracy before and after review of ChatGPT-4o outputs.

    Measured: through study completion, an average of 6 months

  3. Consistency of ChatGPT-4o Responses Across Independent Trials

    Agreement between two independent runs of ChatGPT-4o when evaluating the same clinical cases.

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start12 Jun 2023
  3. Primary completion15 Jan 2025
  4. Study completion1 Mar 2025

Resources

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
Other
Time perspective
Other
Enrolment
100 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493681
Sponsor's protocol ID
485/24
Acronym
REASON
Status last verified
Mar 2026
First submitted
15 Mar 2026
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The complete dataset of Chat-GPT4o outputs generated and analysed during the study will be made available upon publication. The datasets of neurologists outputs generated and analysed during the study will be made available from the corresponding author on reasonable academic request.

Publications

  • Fonseca A, Ferreira A, Ribeiro L, Moreira S, Duque C. Embracing the future-is artificial intelligence already better? A comparative study of artificial intelligence performance in diagnostic accuracy and decision-making. Eur J Neurol. 2024 Apr;31(4):e16195. doi: 10.1111/ene.16195. Epub 2024 Jan 18.

    PubMed 38235841
  • Kanjee Z, Crowe B, Rodman A. Accuracy of a Generative Artificial Intelligence Model in a Complex Diagnostic Challenge. JAMA. 2023 Jul 3;330(1):78-80. doi: 10.1001/jama.2023.8288.

    PubMed 37318797
  • Uwishema O, Boon P. Bridging the Gaps: Addressing Inequities in Neurological Care for Underserved Populations. Eur J Neurol. 2025 Feb;32(2):e70073. doi: 10.1111/ene.70073. No abstract available.

    PubMed 39912252
  • Elafros MA, Kvalsund MP, Callaghan BC. The Global Burden of Polyneuropathy-In Need of an Accurate Assessment. JAMA Neurol. 2022 Jun 1;79(6):537-538. doi: 10.1001/jamaneurol.2022.0565. No abstract available.

    PubMed 35404377

Questions about this trial

What is this clinical trial studying?

An observational study of Polyneuropathies, run by Istituto Clinico Humanitas at 1 site in Italy.

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 1 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 25 Mar 2026. 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 Italy. 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 Accuracy of Leading Diagnosis (time frame: through study completion, an average of 6 months). 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 NCT07493681, which also lists 4 linked publications.

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 25 Mar 2026.

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