Evaluation of an EEG Based Concussion System

Concussion Clinical Trial

Official title:

Evaluation of an EEG Based Concussion System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710109
• Other study ID #: GCO 18-0699
• Status: Recruiting
• Start date: October 23, 2018
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Aidan Rogers, MS
• Phone: 212-824-8369
• Email: aidan.rogers[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Concussion

Intervention

Other:
• EEG
non-invasive, non-interventional sensor

Locations

Country	Name	City	State
United States	Abilities Research Center	New York	New York
United States	Mount Sinai Beth Israel Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady State Visual Evoked Potential	the presence or absence of a steady state visual evoked potential (SSVEP)	up to 28 days