Artificial Intelligence-based Video Analysis to Detect Infantile Spasms

Johns Hopkins University

Status: Enrolling

Conditions: Infantile Spasms

Treatments: Device: Spasm Vision

Study type: Observational

Funder types: Other

Identifiers

NCT06315829

IRB00429753

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Confirmed Epileptic Spasms (Positive Class)

Description:

Participants diagnosed with infantile spasms based upon historical data and supportive electroencephalography data (i.e. hypsarrhythmia or modified hypsarrhythmia background).

Treatment:

Device: Spasm Vision

Epileptic Spasm Mimics (Negative Class)

Description:

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).

Treatment:

Device: Spasm Vision

Awake and Alert (Negative Class)

Description:

Participants exhibiting spontaneous, subtle movements in the awake and alert state.

Treatment:

Device: Spasm Vision