Clinical trial NCT03710109: Evaluation of an EEG Based Concussion System
Official title: Evaluation of an EEG Based Concussion System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Concussion
Keywords: Concussion
Sports Concussion
Sports Medicine
Electroencephalography
Steady state visual evoked potential
Evoked Potential
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals seeking medical attention at the Mount Sinai Hospital System after experiencing a head injury

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
* Healthy Individuals with no recent history of head trauma

Exclusion Criteria:

* 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

Primary outcomes:
measure: Steady State Visual Evoked Potential
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel Hospital
state: New York
city: New York
country: United States
facility: Abilities Research Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: