Seizures Clinical Trial
Official title:
Detecting Absence Seizures Using Eye Tracking
NCT number | NCT04439656 |
Other study ID # | DASEY |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2020 |
Est. completion date | June 28, 2022 |
Verified date | June 2022 |
Source | Eysz, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 28, 2022 |
Est. primary completion date | June 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form- per local IRB 2. Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study 3. Male or female, aged 4-100 4. Experience known typical absence seizures as defined by the ILAE 2017 classification or referred to EEG lab for staring spell or concern for absence seizure a. This will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive 5. Scheduled for clinical EEG observation Exclusion Criteria: 1. Intolerant of wearing or unable to wear the eyeglasses 2. Autism or other developmental disorder that the PI thinks will interfere with data collection 3. History of aggression that the PI thinks will interfere with data collection 4. History of not tolerating EEG that the PI thinks will interfere with data collection 5. Unable to give consent (for individuals = 18 years old) unless they have an adult with power of attorney to consent |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Orange County | Orange | California |
United States | Texas Child Neurology | Plano | Texas |
United States | Rady Children's Hospital, San Diego | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Rachel Kuperman | Children's Hospital of Orange County, University of California, San Francisco, Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eysz algorithm to detect absence seizures | EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify > 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care | 1 hour |
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