Artificial Intelligence-based Video Analysis to Detect Infantile Spasms

Recruiting

• Conditions: Infantile Spasms
• Interventions: Device: Spasm Vision

• Registration Number: NCT06315829
• Lead Sponsor: Johns Hopkins University

Brief Summary

Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Status Verified: 2024-08
• Study Start: 2024-08-26
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Participant age less than 24 months
• Participant evaluated in the Johns Hopkins Outpatient Center, Johns Hopkins Pediatric Emergency Department or Johns Hopkins Inpatient Units due to spells of abnormal movement or seizure
• Participant evaluated by a pediatric neurologist during the outpatient or inpatient visit at Johns Hopkins Hospital
• At least one video recording of the spell of abnormal movement produced by the parent/guardian available for provider review

Exclusion Criteria

• Poor video recording quality
• Entire patient is not in frame

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epileptic Spasm Mimics (Negative Class)	Spasm Vision	Participants diagnosed with non-epileptic movements (e.g. Sandifer syndrome, shuddering attacks, stretching, stereotypy, startle reflex, writhing movements, jitteriness, sleep myoclonus) based upon historical data and supportive electroencephalography data (when available).
Confirmed Epileptic Spasms (Positive Class)	Spasm Vision	Participants diagnosed with infantile spasms based upon historical data and supportive electroencephalography data (i.e. hypsarrhythmia or modified hypsarrhythmia background).
Awake and Alert (Negative Class)	Spasm Vision	Participants exhibiting spontaneous, subtle movements in the awake and alert state.

Primary Outcome Measures

Name	Time	Method
Model Negative Predictive Value	2 years	Proportion of negative classifications which were correct in the test dataset.
Model Sensitivity (Recall)	2 years	Proportion of true positives which the model classified correctly in the test dataset.
Model Positive Predictive Value (Precision)	2 years	Proportion of positive classifications which were correct in the test dataset.
Model Specificity	2 years	Proportion of true negatives which the model classified correctly in the test dataset.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States