- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07817238
Large Language Models for Epidural Stimulation Electrode Mapping in Spinal Cord Injury
AI-Assisted Electrode Contact Configuration Mapping for Epidural Electrical Stimulation in Spinal Cord Injury: A Comparative Evaluation of Large Language Models
This observational and methodological study aims to compare the performance of large language models in generating electrode contact configuration recommendations for epidural electrical stimulation in spinal cord injury.
Five standardized synthetic spinal cord injury scenarios will be presented to four large language models: ChatGPT-4o, Claude, Grok 3, and Gemini 2.5 Pro. Each model will receive the same standardized prompt. The generated responses will be anonymized and evaluated independently by experts with experience in spinal cord injury rehabilitation and epidural electrical stimulation.
The responses will be assessed in five main areas: clinical accuracy, technical feasibility, safety awareness, consistency with current clinical guidance, and completeness of the response. Agreement between expert evaluators will also be examined.
No real patients, human participants, clinical interventions, or personal health data are included in this study. The study is designed to explore the potential and current limitations of large language models as artificial intelligence-based clinical decision-support tools in neurorehabilitation.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Istanbul
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Istanbul, Istanbul, Turquia (Türkiye), 34290
- Istanbul Gelisim University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Responses generated for one of the five predefined standardized synthetic spinal cord injury scenarios.
- Responses generated using the identical standardized prompt specified in the study protocol.
- Responses generated by one of the four prespecified large language models.
- Complete responses available for expert evaluation.
Exclusion Criteria:
- Responses generated using prompts that differ from the standardized study prompt.
- Incomplete, interrupted, or technically corrupted model outputs.
- Duplicate responses or outputs not corresponding to a predefined synthetic scenario.
- Any response generated using real patient-identifiable or personal health information.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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ChatGPT-4o
Responses generated by ChatGPT-4o for five standardized synthetic spinal cord injury scenarios using the same standardized prompt.
The responses will be evaluated for clinical accuracy, technical feasibility, safety awareness, guideline consistency, and completeness.
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The large language model receives five standardized synthetic spinal cord injury scenarios using an identical standardized prompt and generates recommendations for epidural electrical stimulation electrode contact configuration mapping.
No intervention is administered to human participants.
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Claude
Responses generated by Claude for five standardized synthetic spinal cord injury scenarios using the same standardized prompt.
The responses will be evaluated for clinical accuracy, technical feasibility, safety awareness, guideline consistency, and completeness.
|
The large language model receives five standardized synthetic spinal cord injury scenarios using an identical standardized prompt and generates recommendations for epidural electrical stimulation electrode contact configuration mapping.
No intervention is administered to human participants.
|
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Grok 3
Responses generated by Grok 3 for five standardized synthetic spinal cord injury scenarios using the same standardized prompt.
The responses will be evaluated for clinical accuracy, technical feasibility, safety awareness, guideline consistency, and completeness.
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The large language model receives five standardized synthetic spinal cord injury scenarios using an identical standardized prompt and generates recommendations for epidural electrical stimulation electrode contact configuration mapping.
No intervention is administered to human participants.
|
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Gemini 2.5 Pro
Responses generated by Grok 3 for five standardized synthetic spinal cord injury scenarios using the same standardized prompt.
The responses will be evaluated for clinical accuracy, technical feasibility, safety awareness, guideline consistency, and completeness.
|
The large language model receives five standardized synthetic spinal cord injury scenarios using an identical standardized prompt and generates recommendations for epidural electrical stimulation electrode contact configuration mapping.
No intervention is administered to human participants.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical Accuracy Score of Large Language Model Responses
Prazo: At the time of expert evaluation, within 1 week after study initiation
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Clinical accuracy of the epidural electrical stimulation electrode contact configuration recommendations generated by each large language model will be independently evaluated by expert reviewers using a 5-point Likert-type rating scale.
Higher scores indicate greater clinical accuracy of the generated recommendations.
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At the time of expert evaluation, within 1 week after study initiation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Technical Feasibility Score of Large Language Model Responses
Prazo: At expert evaluation, within 1 week after study initiation
|
The technical feasibility of epidural electrical stimulation electrode contact configuration recommendations generated by each large language model will be independently evaluated by expert reviewers using a 5-point Likert-type rating scale.
Higher scores indicate greater technical feasibility and applicability of the generated recommendations.
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At expert evaluation, within 1 week after study initiation
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Safety Awareness Score of Large Language Model Responses
Prazo: At expert evaluation, within 1 week after study initiation
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The safety awareness demonstrated in the epidural electrical stimulation electrode contact configuration recommendations generated by each large language model will be independently evaluated by expert reviewers using a 5-point Likert-type rating scale.
Higher scores indicate greater recognition and consideration of relevant safety issues.
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At expert evaluation, within 1 week after study initiation
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Clinical Guideline Consistency Score of Large Language Model Responses
Prazo: At expert evaluation, within 1 week after study initiation
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The consistency of the generated epidural electrical stimulation electrode contact configuration recommendations with current clinical guidance will be independently evaluated by expert reviewers using a 5-point Likert-type rating scale.
Higher scores indicate greater consistency with current clinical guidance and relevant evidence-based recommendations.
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At expert evaluation, within 1 week after study initiation
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Response Completeness Score of Large Language Model Responses
Prazo: At expert evaluation, within 1 week after study initiation
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The completeness of the epidural electrical stimulation electrode contact configuration recommendations generated by each large language model will be independently evaluated by expert reviewers using a 5-point Likert-type rating scale.
Higher scores indicate more complete and comprehensive responses.
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At expert evaluation, within 1 week after study initiation
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EES-LLM-2026-01
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