- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Istanbul
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Istanbul, Istanbul, Turquie (Türkiye), 34290
- Istanbul Gelisim University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
|
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.
|
|
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.
|
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.
|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Accuracy Score of Large Language Model Responses
Délai: At the time of expert evaluation, within 1 week after study initiation
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Technical Feasibility Score of Large Language Model Responses
Délai: 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.
|
At expert evaluation, within 1 week after study initiation
|
|
Safety Awareness Score of Large Language Model Responses
Délai: At expert evaluation, within 1 week after study initiation
|
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.
|
At expert evaluation, within 1 week after study initiation
|
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Clinical Guideline Consistency Score of Large Language Model Responses
Délai: At expert evaluation, within 1 week after study initiation
|
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
|
|
Response Completeness Score of Large Language Model Responses
Délai: At expert evaluation, within 1 week after study initiation
|
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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EES-LLM-2026-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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