Detecting Absence Seizures Using Eye Tracking | NCT04439656

Studies
Detecting Absence Seizures Using Eye Tracking

NCT04439656

Sponsor

Rachel Kuperman

Status

Completed

Last Update Posted

Jul 5, 2022Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Epilepsy, Generalized
Absence Epilepsy
Absence Seizures
Seizures
Seizure Disorder

Interventions

Eye movement analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

Jun 28, 2022Actual

Completion Date

Jun 28, 2022Actual

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jul 5, 2022Actual

Name	Class
Children's Hospital of Orange County	OTHER
University of California, San Francisco	OTHER
Wake Forest University Health Sciences	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Absence Seizures		Participants with absence seizures will have their eye movements compared to the EEG recording.	Diagnostic Test: Eye movement analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eye movement analysis	Diagnostic Test	Eye movements will be analyzed to identify if seizures are present and compared to the EEG read	Absence Seizures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed and dated informed consent form- per local IRB
Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study
Male or female, aged 4-100
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
Scheduled for clinical EEG observation

Exclusion Criteria:

Intolerant of wearing or unable to wear the eyeglasses
Autism or other developmental disorder that the PI thinks will interfere with data collection
History of aggression that the PI thinks will interfere with data collection
History of not tolerating EEG that the PI thinks will interfere with data collection
Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Children or adults with absence seizures.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Rachel Kuperman, MD	Eysz, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Orange County		Orange	California	92868	United States
Rady Children's Hospital, San Diego

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004829	Epilepsy, Generalized
D004832	Epilepsy, Absence
D012640	Seizures
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000073376	Epileptic Syndromes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000084542	Eye-Tracking Technology

Ancestor Terms

ID	Term
D053483	Eye Movement Measurements
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided