Evaluation of an EEG Based Concussion System

November 13, 2023 updated by: David Putrino, Icahn School of Medicine at Mount Sinai

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai Beth Israel Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Putrino, PT,PhD
      • New York, New York, United States, 10029
        • Recruiting
        • Abilities Research Center
        • Principal Investigator:
          • David Putrino, PT,PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Concussion
Individuals who have sustained a recent concussion
Other: EEG
non-invasive, non-interventional sensor
Control Healthy Volunteers
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steady State Visual Evoked Potential
Time Frame: up to 28 days
the presence or absence of a steady state visual evoked potential (SSVEP)
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: David Putrino, PT, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2018

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GCO 18-0699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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