Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detecting Absence Seizures Using Eye Tracking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439656
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : November 19, 2021
Sponsor:
Collaborators:
Rady Children's Hospital, San Diego
Children's Hospital of Orange County
University of California, San Francisco
Wake Forest University Health Sciences
Texas Child Neurology
Information provided by (Responsible Party):
Rachel Kuperman, Eysz, Inc.

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.

Condition or disease Intervention/treatment
Epilepsy, Generalized Absence Epilepsy Absence Seizures Seizures Seizure Disorder Diagnostic Test: Eye movement analysis

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Other
Official Title: Detecting Absence Seizures Using Eye Tracking
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
Absence Seizures
Participants with absence seizures will have their eye movements compared to the EEG recording.
Diagnostic Test: Eye movement analysis
Eye movements will be analyzed to identify if seizures are present and compared to the EEG read




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children or adults with absence seizures.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439656


Contacts
Layout table for location contacts
Contact: Rachel Kuperman, MD ‪(415) 857-1794‬ rkuperman@eyszlab.com

Locations
Layout table for location information
United States, California
Children's Hospital Orange County Recruiting
Orange, California, United States, 92868
Contact: Linda Do    714-509-8945    Linh.Do@choc.org   
Principal Investigator: Donald Phillips, MD         
Rady Children's Hospital, San Diego Recruiting
San Diego, California, United States, 92123
Contact: Maira Suarez       mnsuarez@rchsd.org   
Principal Investigator: Shifteh Sattar, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Lucy Liu       lucy.liu3@ucsf.edu   
Principal Investigator: Danilo Bernardo, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Deanna Oates    336-716-4101    doates@wakehealth.edu   
Principal Investigator: Heidi Munger Clary, MD, MPH         
United States, Texas
Texas Child Neurology Recruiting
Plano, Texas, United States, 75024
Contact: Crystal Morton    972-769-9000    cmorton@texaschildneurology.com   
Principal Investigator: Daniel Gossett, MD         
Sponsors and Collaborators
Rachel Kuperman
Rady Children's Hospital, San Diego
Children's Hospital of Orange County
University of California, San Francisco
Wake Forest University Health Sciences
Texas Child Neurology
Investigators
Layout table for investigator information
Principal Investigator: Rachel Kuperman, MD Eysz, Inc.
Layout table for additonal information
Responsible Party: Rachel Kuperman, Director, Clinical Research, Eysz, Inc.
ClinicalTrials.gov Identifier: NCT04439656    
Other Study ID Numbers: DASEY
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rachel Kuperman, Eysz, Inc.:
eye movements
seizure detection
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Seizures
Epilepsy, Absence
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Epileptic Syndromes