- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34290
- Istanbul Gelisim University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Accuracy Score of Large Language Model Responses
Time Frame: 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.
|
At the time of expert evaluation, within 1 week after study initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical Feasibility Score of Large Language Model Responses
Time Frame: 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
Time Frame: 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
|
|
Clinical Guideline Consistency Score of Large Language Model Responses
Time Frame: 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.
|
At expert evaluation, within 1 week after study initiation
|
|
Response Completeness Score of Large Language Model Responses
Time Frame: 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.
|
At expert evaluation, within 1 week after study initiation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EES-LLM-2026-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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