Infantile Spasms Clinical Trial
Official title:
A Machine Learning Approach to Infantile Spasms Recognition in Video Recordings
NCT number | NCT06315829 |
Other study ID # | IRB00429753 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2024 |
Est. completion date | May 2026 |
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Model Sensitivity (Recall) | Proportion of true positives which the model classified correctly in the test dataset. | 2 years | |
Primary | Model Specificity | Proportion of true negatives which the model classified correctly in the test dataset. | 2 years | |
Primary | Model Positive Predictive Value (Precision) | Proportion of positive classifications which were correct in the test dataset. | 2 years | |
Primary | Model Negative Predictive Value | Proportion of negative classifications which were correct in the test dataset. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02299115 -
Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
|
Phase 3 | |
Completed |
NCT02885389 -
Molecular Genetics in Infantile Spasms
|
N/A | |
Completed |
NCT01006811 -
Use of the Modified Atkins Diet in Infantile Spasms
|
Phase 2/Phase 3 | |
Completed |
NCT01828437 -
Addition of Pyridoxine to Prednisolone in Infantile Spasms
|
Phase 3 | |
Recruiting |
NCT01858285 -
Genetics of Epilepsy and Related Disorders
|
||
Completed |
NCT00552045 -
Epilepsy Phenome/Genome Project
|
||
Completed |
NCT02220114 -
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
|
N/A | |
Completed |
NCT02954887 -
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
|
Phase 3 | |
Completed |
NCT01723787 -
Genetic Studies in Patients and Families With Infantile Spasms
|
||
Completed |
NCT02092883 -
Evaluation of Neuroinflammation in Children With Infantile Spasms
|
Phase 4 | |
Withdrawn |
NCT01413711 -
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
|
Phase 4 | |
Terminated |
NCT00442104 -
Open-label Extension to Protocol 1042-0500
|
Phase 2 | |
Completed |
NCT00441896 -
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
|
Phase 2 | |
Withdrawn |
NCT01549288 -
Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy
|
Phase 2/Phase 3 | |
Completed |
NCT01575639 -
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
|
Phase 3 | |
Completed |
NCT01073579 -
Sabril Patient Registry
|
N/A | |
Completed |
NCT02953548 -
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
|
Phase 3 | |
Completed |
NCT00001325 -
Metabolic Abnormalities in Children With Epilepsy
|
N/A | |
Completed |
NCT00968136 -
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
|
N/A |