Infantile SpasmsNCT06315829
Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
An observational study of Infantile Spasms, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Infantile Spasms
- What is being tested?
- Spasm Vision
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 6 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited from the outpatient and inpatient settings of Johns Hopkins Hospital, an academic medical center located in Baltimore, Maryland offering tertiary and quaternary care.
Who may be able to join
- 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
Who cannot join
- Poor video recording quality
- Entire patient is not in frame
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Machine Learning Approach to Infantile Spasms Recognition in Video Recordings
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.
- Conditions
- Infantile Spasms
- Being tested
- Spasm Vision
- Keywords
- Seizure, Epilepsy, Infantile Spasm, Epileptic Spasm, West Syndrome, Hypsarrhythmia, Artificial Intelligence, Video Analysis, Computer Vision, Machine Learning
- Medical subject headings
- Spasms, Infantile, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spasm VisionDevice
Machine learning software developed to analyze videos and accurately distinguish infantile spasms from visually similar movements.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed Epileptic Spasms (Positive Class) | Participants diagnosed with infantile spasms based upon historical data and supportive electroencephalography data (i.e. hypsarrhythmia or modified hypsarrhythmia background). Receives: Device: Spasm Vision | |
| Epileptic Spasm Mimics (Negative Class) | 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). Receives: Device: Spasm Vision | |
| Awake and Alert (Negative Class) | Participants exhibiting spontaneous, subtle movements in the awake and alert state. Receives: Device: Spasm Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model Sensitivity (Recall)
Proportion of true positives which the model classified correctly in the test dataset.
Measured: 2 years
Model Specificity
Proportion of true negatives which the model classified correctly in the test dataset.
Measured: 2 years
Model Positive Predictive Value (Precision)
Proportion of positive classifications which were correct in the test dataset.
Measured: 2 years
Model Negative Predictive Value
Proportion of negative classifications which were correct in the test dataset.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start26 Aug 2024
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile SpasmsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Kossoff, MD, Principal investigator, Johns Hopkins NeurologyRama Chellappa, PhD, Principal investigator, Johns Hopkins Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315829
- Sponsor's protocol ID
- IRB00429753
- Status last verified
- May 2026
- First submitted
- 11 Mar 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach to Infantile Spasms Recognition in Video Recordings
- ClinicalTrials.gov ID
- NCT06315829
- Acronym / sponsor ID
- IRB00429753
- Conditions
- Infantile Spasms
- Keywords
- Seizure, Epilepsy, Infantile Spasm, Epileptic Spasm, West Syndrome, Hypsarrhythmia, Artificial Intelligence, Video Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Confirmed Epileptic Spasms (Positive Class) | – | Device: Spasm VisionParticipants diagnosed with infantile spasms based upon historical data and supportive electroencephalography data (i.e. hypsarrhythmia or modified hypsarrhythmia background). |
| Epileptic Spasm Mimics (Negative Class) | – | Device: Spasm VisionParticipants 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). |
| Awake and Alert (Negative Class) | – | Device: Spasm VisionParticipants exhibiting spontaneous, subtle movements in the awake and alert state. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited from the outpatient and inpatient settings of Johns Hopkins Hospital, an academic medical center located in Baltimore, Maryland offering tertiary and quaternary care.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Poor video recording quality
- Entire patient is not in frame
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spasm VisionMachine learning software developed to analyze videos and accurately distinguish infantile spasms from visually similar movements. | Device | Awake and Alert (Negative Class), Confirmed Epileptic Spasms (Positive Class), Epileptic Spasm Mimics (Negative Class) |
Primary outcome
Model Sensitivity (Recall)
Time frame: 2 years
Proportion of true positives which the model classified correctly in the test dataset.
Model Specificity
Time frame: 2 years
Proportion of true negatives which the model classified correctly in the test dataset.
Model Positive Predictive Value (Precision)
Time frame: 2 years
Proportion of positive classifications which were correct in the test dataset.
Model Negative Predictive Value
Time frame: 2 years
Proportion of negative classifications which were correct in the test dataset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Infantile Spasms
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A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
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RecruitingPhase 2
Treatment of Refractory Infantile Spasms With Fenfluramine
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RecruitingObservational study
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Kossoff, MD principal investigator
Johns Hopkins Neurology
Rama Chellappa, PhD principal investigator
Johns Hopkins Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Spasms, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model Sensitivity (Recall) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.