Evaluation of an EEG Based Concussion System

NCT03710109 | Recruiting

• 1 other identifier: GCO 18-0699
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Concussion

Keywords

Concussion; Sports Concussion; Sports Medicine; Electroencephalography; Steady state visual evoked potential; Evoked Potential

Outcome Measures

Primary Outcomes (1)

• Steady State Visual Evoked Potential

  the presence or absence of a steady state visual evoked potential (SSVEP)

  up to 28 days

Study Arms (2)

Concussion

Individuals who have sustained a recent concussion

Other: EEG

Control Healthy Volunteers

No Intervention

Interventions

EEG OTHER

non-invasive, non-interventional sensor

Concussion

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals seeking medical attention at the Mount Sinai Hospital System after experiencing a head injury

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai Beth Israel Hospital

New York, New York, 10003, United States

RECRUITING

Abilities Research Center

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aidan Rogers, MS

CONTACT

212-824-8369; aidan.rogers@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: October 23, 2018
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)