Epilepsy, GeneralizedNCT04439656
Detecting Absence Seizures Using Eye Tracking
An observational study of Epilepsy, Generalized and Absence Epilepsy, run by Rachel Kuperman at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 100 years
- Conditions the study is for
- Epilepsy, Generalized, Absence Epilepsy, Absence Seizures
- What is being tested?
- Eye movement analysis
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jul 2020to 28 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children or adults with absence seizures.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Hospital Orange County
Orange, California, 92868
Texas Child Neurology
Plano, Texas, 75024
Rady Children's Hospital, San Diego
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94158
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Being tested
- Eye movement analysis
- Keywords
- eye movements, seizure detection
- Medical subject headings
- Epilepsy, Generalized, Epilepsy, Absence, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye movement analysisDiagnostic test
Eye movements will be analyzed to identify if seizures are present and compared to the EEG read
| Study group | Role | What they receive |
|---|---|---|
| Absence Seizures | Participants with absence seizures will have their eye movements compared to the EEG recording. Receives: Diagnostic Test: Eye movement analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start15 Jul 2020
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Kuperman
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Orange County, University of California, San Francisco, Wake Forest University Health Sciences
- Responsible party
- Sponsor-investigator, Rachel Kuperman, Eysz, Inc.
- Investigators
- Rachel Kuperman, MD, Principal investigator, Eysz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439656
- Sponsor's protocol ID
- DASEY
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Absence Seizures Using Eye Tracking
- ClinicalTrials.gov ID
- NCT04439656
- Acronym / sponsor ID
- DASEY
- Keywords
- eye movements, seizure detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rachel KupermanIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Orange County, University of California, San Francisco, Wake Forest University Health Sciences
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absence Seizures | – | Diagnostic Test: Eye movement analysisParticipants with absence seizures will have their eye movements compared to the EEG recording. |
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children or adults with absence seizures.
Key inclusion criteria (6 listed)
- 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
- Scheduled for clinical EEG observation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye movement analysisEye movements will be analyzed to identify if seizures are present and compared to the EEG read | Diagnostic test | Absence Seizures |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Kuperman, MD principal investigator
Eysz, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Generalized and Absence Epilepsy, run by Rachel Kuperman at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eysz algorithm to detect absence seizures (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.