ConcussionNCT03710109
Evaluation of an EEG Based Concussion System
An observational study of Concussion, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This study will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Concussion
- What is being tested?
- EEG
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2018to 17 Mar 2025
- 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 9 years and older
- All sexes
- Child, Adult, Older adult
Study population: Individuals seeking medical attention at the Mount Sinai Hospital System after experiencing a head injury
Who may be able to join
- Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
- Healthy Individuals with no recent history of head trauma
Who cannot join
- Known history of epilepsy or any other seizure disorder
- Legally blind
- Reduced capacity to consent if there is not a Legally Authorized Representative (LAR) present
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Beth Israel Hospital
New York, New York, 10003
Abilities Research Center
New York, New York, 10029
About this study
This study will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. The system captures an electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual. The device is not FDA approved, but it is a non-significant risk device. The device is a non-invasive, non-interventional sensor. It will not replace the opinion of the physician in diagnosing a concussion.
This study will test the EEG based concussion system on 200 individuals, Participants will be made up of individuals who are seeking medical consultation at the Play Safe Concussion Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave, New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The doctors who see patients these locations will be involved in conducting this research. In addition to the standard-of-care clinical assessments, participants will also receive an evaluation from the concussion based system.
Read more
When a subject experiences a head trauma, the subject will be evaluated for a concussion by both the standard-of-care clinical assessments. The treating physician will provide all necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose and treat each patient and by the new concussion system. The researchers will also collect data from healthy, age-matched controls in order to collect a database of healthy responses to the technology.
To determine how accurate the new concussion system is at detecting concussions, the research team will compare the diagnostic results from the device to the diagnostic results of the doctor's assessments. The goal of this study is to develop a device that can give sound advice as to whether an individual should seek medical attention for a possible concussion following a head injury.
- Conditions
- Concussion
- Being tested
- EEG
- Keywords
- Concussion, Sports Concussion, Sports Medicine, Electroencephalography, Steady state visual evoked potential, Evoked Potential
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGOther
non-invasive, non-interventional sensor
| Study group | Role | What they receive |
|---|---|---|
| Concussion | Individuals who have sustained a recent concussion Receives: Other: EEG | |
| Control Healthy Volunteers | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady State Visual Evoked Potential
the presence or absence of a steady state visual evoked potential (SSVEP)
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start23 Oct 2018
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Why it stopped: recruitment has slowed severely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PT, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710109
- Sponsor's protocol ID
- GCO 18-0699
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2018
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an EEG Based Concussion System
- ClinicalTrials.gov ID
- NCT03710109
- Acronym / sponsor ID
- GCO 18-0699
- Conditions
- Concussion
- Keywords
- Concussion, Sports Concussion, Sports Medicine, Electroencephalography, Steady state visual evoked potential, Evoked Potential
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment has slowed severely
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 17 Oct 2018 (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 will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. The system captures an electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual. The device is not FDA approved, but it is a non-significant risk device. The device is a non-invasive, non-interventional sensor. It will not replace the opinion of the physician in diagnosing a concussion.
This study will test the EEG based concussion system on 200 individuals, Participants will be made up of individuals who are seeking medical consultation at the Play Safe Concussion Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave, New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The doctors who see patients these locations will be involved in conducting this research. In addition to the standard-of-care clinical assessments, participants will also receive an evaluation from the concussion based system.
When a subject experiences a head trauma, the subject will be evaluated for a concussion by both the standard-of-care clinical assessments. The treating physician will provide all necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose and treat each patient and by the new concussion system. The researchers will also collect data from healthy, age-matched controls in order to collect a database of healthy responses to the technology.
To determine how accurate the new concussion system is at detecting concussions, the research team will compare the diagnostic results from the device to the diagnostic results of the doctor's assessments. The goal of this study is to develop a device that can give sound advice as to whether an individual should seek medical attention for a possible concussion following a head injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion | – | Other: EEGIndividuals who have sustained a recent concussion |
| Control Healthy Volunteers | – | –No Intervention |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals seeking medical attention at the Mount Sinai Hospital System after experiencing a head injury
Key inclusion criteria (2 listed)
- Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
- Healthy Individuals with no recent history of head trauma
Key exclusion criteria (3 listed)
- Known history of epilepsy or any other seizure disorder
- Legally blind
- Reduced capacity to consent if there is not a Legally Authorized Representative (LAR) present
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 |
|---|---|---|
| EEGnon-invasive, non-interventional sensor | Other | Concussion |
Primary outcome
Steady State Visual Evoked Potential
Time frame: up to 28 days
the presence or absence of a steady state visual evoked potential (SSVEP)
Results and safety
The study was stopped early (reason given: recruitment has slowed severely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Concussion
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Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
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Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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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.
David Putrino, PT, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, run by Icahn School of Medicine at Mount Sinai at 2 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: recruitment has slowed severely). Results are not available in the source record.
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?
Steady State Visual Evoked Potential (time frame: up to 28 days). 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 18 May 2026.