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Detecting Absence Seizures Using Eye Tracking

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ClinicalTrials.gov Identifier: NCT04439656
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : May 18, 2022
Sponsor:
Collaborators:
Children's Hospital of Orange County
University of California, San Francisco
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Rachel Kuperman, Eysz, Inc.

Tracking Information
First Submitted Date June 17, 2020
First Posted Date June 19, 2020
Last Update Posted Date May 18, 2022
Actual Study Start Date July 15, 2020
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2020)
Eysz algorithm to detect absence seizures [ Time Frame: 1 hour ]
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detecting Absence Seizures Using Eye Tracking
Official Title Detecting Absence Seizures Using Eye Tracking
Brief Summary 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.
Detailed Description Seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. 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. People participating in this study will have a routine EEG performed while an eye tracker measures eye movements. After the EEG is complete the researchers will compare the eye movements to the EEG to develop a software program that can detect seizures from eye movements.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children or adults with absence seizures.
Condition
  • Epilepsy, Generalized
  • Absence Epilepsy
  • Absence Seizures
  • Seizures
  • Seizure Disorder
Intervention Diagnostic Test: Eye movement analysis
Eye movements will be analyzed to identify if seizures are present and compared to the EEG read
Study Groups/Cohorts Absence Seizures
Participants with absence seizures will have their eye movements compared to the EEG recording.
Intervention: Diagnostic Test: Eye movement analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2020)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2023
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rachel Kuperman, MD ‪(415) 857-1794‬ rkuperman@eyszlab.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04439656
Other Study ID Numbers DASEY
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rachel Kuperman, Eysz, Inc.
Study Sponsor Rachel Kuperman
Collaborators
  • Children's Hospital of Orange County
  • University of California, San Francisco
  • Wake Forest University Health Sciences
Investigators
Principal Investigator: Rachel Kuperman, MD Eysz, Inc.
PRS Account Eysz, Inc.
Verification Date May 2022