ADHD - Combined TypeNCT04504890
Ocular-vestibular Biomarker Identification for ADHD
An observational study of ADHD - Combined Type and ADHD, run by Sync-Think, Inc. at 1 site in United States.
Trial summary
This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- ADHD - Combined Type, ADHD, ADHD Predominantly Inattentive Type
- What is being tested?
- EYE-SYNC
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 5 Oct 2021
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adults seeking diagnosis and/or treatment for attention-related disorder.
Who may be able to join
- Men and women ages 6-70 seeking evaluation and treatment for ADHD.
Who cannot join
- Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.
- Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism.
- Psychiatric history with any of the following:
- LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder
- LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder
- Use of a psychotropic medication
- Impairment of cranial nerves II-VI
- Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Palo Alto Medical Foundation - San Carlos Center
San Carlos, California, 94070
Benjamin Cheyette, M.D., Ph.D., 650-278-1814, cheyetbr@sutterhealth.org
Sarah Cheyette, M.D., CheyetS@sutterhealth.org
About this study
This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.
Read the detailed description
This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.
- Conditions
- ADHD - Combined Type, ADHD, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Being tested
- EYE-SYNC
- Keywords
- ADHD, EYE-SYNC, eye tracking, oculomotor, vestibular
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE-SYNCDevice
Nystagmograph used to measure eye movement
| Study group | Role | What they receive |
|---|---|---|
| Adults - Diagnosis | Adults seeking treatment for an attention-related disorder Receives: Device: EYE-SYNC | |
| Adults - Prescribed | Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder Receives: Device: EYE-SYNC | |
| Children - Diagnosis | Children seeking treatment for an attention-related disorder Receives: Device: EYE-SYNC | |
| Children - Prescribed | Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder Receives: Device: EYE-SYNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Tracking and ADHD measure correlation
Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables
Measured: through study completion, an average of 1 year
Eye Tracking ADHD Diagnostic ROC
Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes
Measured: through study completion, an average of 1 year
MANCOVA Eye Tracking in ADHD Treatment Population
Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start16 Jul 2020
- Primary completion5 Aug 2021 (estimated)
- Study completion5 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Combined TypeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sync-Think, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sutter Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504890
- Sponsor's protocol ID
- EYESYNCOBIADHD2020
- Status last verified
- Oct 2020
- First submitted
- 5 Aug 2020
- Last updated
- 23 Oct 2020
- 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 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular-vestibular Biomarker Identification for ADHD
- ClinicalTrials.gov ID
- NCT04504890
- Acronym / sponsor ID
- EYESYNCOBIADHD2020
- Conditions
- ADHD - Combined Type, ADHD, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Keywords
- ADHD, EYE-SYNC, eye tracking, oculomotor, vestibular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sync-Think, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sutter Health
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 5 Aug 2021 (estimated)
- Study completion
- 5 Oct 2021 (estimated)
- First posted
- 7 Aug 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.
This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.
Detailed description
This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adults - Diagnosis | – | Device: EYE-SYNCAdults seeking treatment for an attention-related disorder |
| Adults - Prescribed | – | Device: EYE-SYNCAdults who have been diagnosed with ADHD and prescribed medication treatment for the disorder |
| Children - Diagnosis | – | Device: EYE-SYNCChildren seeking treatment for an attention-related disorder |
| Children - Prescribed | – | Device: EYE-SYNCChildren who have been diagnosed with ADHD and prescribed medication treatment for the disorder |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults seeking diagnosis and/or treatment for attention-related disorder.
Key inclusion criteria (1 listed)
- Men and women ages 6-70 seeking evaluation and treatment for ADHD.
Key exclusion criteria (8 listed)
- Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.
- LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder
- LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder
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-SYNCNystagmograph used to measure eye movement | Device | Adults - Diagnosis, Adults - Prescribed, Children - Diagnosis, Children - Prescribed |
Primary outcome
Eye Tracking and ADHD measure correlation
Time frame: through study completion, an average of 1 year
Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables
Eye Tracking ADHD Diagnostic ROC
Time frame: through study completion, an average of 1 year
Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes
MANCOVA Eye Tracking in ADHD Treatment Population
Time frame: through study completion, an average of 1 year
Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD - Combined Type and ADHD, run by Sync-Think, Inc. at 1 site 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Cheyette, M.D.,Ph.D. (650.278.1814, cheyetbr@sutterhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Tracking and ADHD measure correlation (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 23 Oct 2020.